Resume Keay Wu
•
1 like•231 views
Keay Wu has over 20 years of experience in quality control and quality assurance for biopharmaceutical companies. He has managed teams of up to 30 employees and overseen quality control laboratories. Wu has strong experience with GMP manufacturing facilities and utilities including purified water and steam systems. He is an effective leader known for coaching employees and maintaining productive relationships.
Report
Share
Report
Share
Download to read offline
Recommended
KFRes_0916
The document provides a profile and work history for Kevin F. Foy, highlighting his experience over 25 years in quality assurance, reliability, and customer satisfaction roles in the manufacturing industry. Foy has a proven track record of developing quality systems, improving yields and reliability, reducing costs, and ensuring compliance at companies including Agilent Technologies, MKS Instruments, Analogic, Celestica, and BFGoodrich Aerospace. His expertise includes implementing process improvements, problem solving, and developing global supplier networks.
Salient Features Of Quality Assurance
Quality assurance is a system used to ensure high quality in products. It involves activities like technology transfer, validation, documentation control, assuring the quality of products, and creating quality improvement plans. The goal is for quality assurance to cover all aspects that can influence and improve the quality of what an organization produces.
K11619 rishabh jain
This document discusses quality assurance in manufacturing. It defines quality as producing consistent products that meet customer expectations. Quality assurance is described as a process that ensures quality policies are followed and final product acceptance. It should be independent and have management support. Ensuring safety and meeting customer expectations are also discussed. The role of quality assurance in manufacturing is to systematically prevent defects and ensure products meet specifications. Quality should be built into products through things like manufacturing travelers, procedures, and inspections. Two case studies provide examples of quality assurance methods for resin infusion and using software to unify quality assurance processes for a semiconductor company.
Quality Management Plan
This document outlines Team Epsilon's Quality Management Plan. It defines the purpose of the QM plan as ensuring quality is planned for and describes how quality will be managed through quality assurance and control activities using defined standards and metrics. The approach involves the project team, metrics, and a quality group. Metrics cover schedule, resources, process, and product performance. Quality assurance tools assess processes based on acceptable standards and performance at intervals. Quality control tools measure features against required values and determine if they are acceptable or need recommendations for resolution. The process focuses on planning, strategy, resources, tools, and is continuous after launch.
Introdution of qa qc
Quality assurance involves planned activities to ensure requirements for quality are fulfilled, while quality control refers to operational techniques used to satisfy quality requirements. Some key differences are that quality assurance is more process-focused and proactive, aiming to prevent defects, while quality control is product-focused and reactive, finding defects. Examples provided illustrate quality control as line functions like testing and inspection, while quality assurance covers staff functions like auditing, process definition, and training.
What is quality
The document discusses quality assurance and quality control. Quality assurance is a proactive process that focuses on processes and preventing defects by understanding requirements upfront and developing plans to meet them. Quality control is reactive and focuses on operational activities like inspection and testing to identify defects and ensure deliverables meet requirements. The quality control process receives input from quality assurance, and if defects are found during quality control, quality assurance will investigate and implement corrective actions to prevent reoccurrence.
QA vs QC
QA and QC both aim to ensure quality, but they differ in their focus and approach. QA is process-oriented and focuses on defect prevention through planned activities and documentation to improve processes. The goal of QA is to prevent defects. In contrast, QC is product-oriented and focuses on defect identification by testing finished products. The goal of QC is to identify and correct defects after product development. Together, QA and QC work to continually meet customer requirements and product quality standards.
Department Objectives
The CIS Production Support 2000 department has several objectives for the year including improving customer satisfaction, stabilizing and improving the production environment, reducing project cycle times, transferring application knowledge to team members, and developing metrics to measure customer expectations and department performance. Leadership will focus on developing processes to transfer knowledge, stabilize production, improve development handoffs, and gather customer feedback.
Recommended
KFRes_0916
The document provides a profile and work history for Kevin F. Foy, highlighting his experience over 25 years in quality assurance, reliability, and customer satisfaction roles in the manufacturing industry. Foy has a proven track record of developing quality systems, improving yields and reliability, reducing costs, and ensuring compliance at companies including Agilent Technologies, MKS Instruments, Analogic, Celestica, and BFGoodrich Aerospace. His expertise includes implementing process improvements, problem solving, and developing global supplier networks.
Salient Features Of Quality Assurance
Quality assurance is a system used to ensure high quality in products. It involves activities like technology transfer, validation, documentation control, assuring the quality of products, and creating quality improvement plans. The goal is for quality assurance to cover all aspects that can influence and improve the quality of what an organization produces.
K11619 rishabh jain
This document discusses quality assurance in manufacturing. It defines quality as producing consistent products that meet customer expectations. Quality assurance is described as a process that ensures quality policies are followed and final product acceptance. It should be independent and have management support. Ensuring safety and meeting customer expectations are also discussed. The role of quality assurance in manufacturing is to systematically prevent defects and ensure products meet specifications. Quality should be built into products through things like manufacturing travelers, procedures, and inspections. Two case studies provide examples of quality assurance methods for resin infusion and using software to unify quality assurance processes for a semiconductor company.
Quality Management Plan
This document outlines Team Epsilon's Quality Management Plan. It defines the purpose of the QM plan as ensuring quality is planned for and describes how quality will be managed through quality assurance and control activities using defined standards and metrics. The approach involves the project team, metrics, and a quality group. Metrics cover schedule, resources, process, and product performance. Quality assurance tools assess processes based on acceptable standards and performance at intervals. Quality control tools measure features against required values and determine if they are acceptable or need recommendations for resolution. The process focuses on planning, strategy, resources, tools, and is continuous after launch.
Introdution of qa qc
Quality assurance involves planned activities to ensure requirements for quality are fulfilled, while quality control refers to operational techniques used to satisfy quality requirements. Some key differences are that quality assurance is more process-focused and proactive, aiming to prevent defects, while quality control is product-focused and reactive, finding defects. Examples provided illustrate quality control as line functions like testing and inspection, while quality assurance covers staff functions like auditing, process definition, and training.
What is quality
The document discusses quality assurance and quality control. Quality assurance is a proactive process that focuses on processes and preventing defects by understanding requirements upfront and developing plans to meet them. Quality control is reactive and focuses on operational activities like inspection and testing to identify defects and ensure deliverables meet requirements. The quality control process receives input from quality assurance, and if defects are found during quality control, quality assurance will investigate and implement corrective actions to prevent reoccurrence.
QA vs QC
QA and QC both aim to ensure quality, but they differ in their focus and approach. QA is process-oriented and focuses on defect prevention through planned activities and documentation to improve processes. The goal of QA is to prevent defects. In contrast, QC is product-oriented and focuses on defect identification by testing finished products. The goal of QC is to identify and correct defects after product development. Together, QA and QC work to continually meet customer requirements and product quality standards.
Department Objectives
The CIS Production Support 2000 department has several objectives for the year including improving customer satisfaction, stabilizing and improving the production environment, reducing project cycle times, transferring application knowledge to team members, and developing metrics to measure customer expectations and department performance. Leadership will focus on developing processes to transfer knowledge, stabilize production, improve development handoffs, and gather customer feedback.
Qa vs qc (yes)
QA is a set of proactive activities that focuses on processes to prevent defects by identifying weaknesses, while QC is a set of reactive activities that focuses on identifying and correcting defects in finished products. The goal of QA is to improve development processes so no defects arise, while the goal of QC is to identify defects after development before release.
Tugas qc vs qa fredy & andreas
This document compares and contrasts quality assurance and quality control. It defines quality control as focusing on fulfilling quality requirements through inspection and measurement, while quality assurance provides confidence that requirements will be fulfilled through planned and systematic activities. Quality control happens after work is completed and finds defects, while quality assurance prevents defects by focusing on processes and continuous improvement. The key difference is that quality control checks outputs, while quality assurance manages the system that creates the outputs.
Quality Assurance in Aviation
This was presented in a seminar organized by Pakistan Civil Aviation Authority on 9th Nov 2017 - World Quality Day
Case Study: Telecom Equipment Manufacturer Enhances QMS to Streamline Returns...
In order to meet increasing customer demand, a Fortune 500 Telecom Equipment Manufacturer added another remanufactured product line to their Special Customer Operations returns center. Spinnaker, who managed the client’s returns functions, was asked to provide more product processing; including testing and light manufacturing work. They were asked to evaluate the existing Digital Equipment Facility Testing (DEFT) lab protocols and product inspection processes to streamline operations and create new material workflows.
Importance of Quality Assurance
Here we discuss what Quality Assurance is as well as its benefits and the detriments associated with a lack of QA.
Kishor Ingale -QA
Kishor Ingale is seeking a senior level position in quality assurance with a reputable organization. He has over 30 years of experience implementing quality standards and systems to ensure regulatory compliance. Some of his core responsibilities include conducting audits, establishing quality procedures, and tracking non-conformances. He is skilled at identifying quality issues and recommending process improvements. Ingale holds an M.Sc. in Total Quality Management and has received additional training in areas such as auditing and six sigma. He is proficient in Microsoft Office applications.
Duties & Responsibilities of Quality Assurance Managers
Quality assurance managers play an important role in business by ensuring that products meet certain thresholds of acceptableness. They plan direct or coordinate quality assurance programs and formulate quality control policies. They also work to enhance an organization's efficiency and profitableness by reducing waste. If you're conscientious, inquisitive and committed to excellence, you'll realize it gratifying to work in this quality compliance occupation.
Design, standards and quality assurance
The document discusses quality assurance practices in aviation. It explains that aviation quality assurance systems monitor equipment, programs, and procedures to ensure Federal Aviation Administration standards are met. Key aviation quality assurance programs discussed include the Flight Operational Quality Assurance program and Aviation Safety Action Program, which analyze flight data to assess safety. Aircraft maintenance technicians are also subject to quality standards regarding inspections, maintenance, and repairs. The document outlines several primary aviation safety programs and notes that proper aircraft maintenance is essential for safety.
Cv | srinivas routhu | Quality Assurance | 10+ yrs experience
• Competent professional with 10+ years of experience in executing
In-process quality assurance by monitoring complete pharma
manufacturing process in order to comply with the specifications
• Over all responsible for IPQA Activities (both manufacturing and
packing area of solid orals, Nasal spray and Liquid dosage forms)
• Ensure the compliance of quality events like deviation
management, temporary change control, permanent change control, CAPA, Market complaints.etc.
• Active participation in root cause investigation and proposal of CAPA for deviation, market complaint and batch failure.
• Effectiveness check of implemented CAPA in shop floor.
• Calibration Management –ensure calibration of all IPQA instruments as per schedule.
• Skilled in preparation and review of Annual Product Quality Review (APQRs)
• Review of SOPs/work instructions-Gap identification and compliance of the same.
• Conducting in-house cGMP audits to ensure compliance and sound functioning of the process.
• Provide training regarding any changes to existing system and introduction of any new system.
• Knowledge on OOS, OOT, Site Master File.
• Hands-on experience in preparation of Process validations, cleaning validation, hold time study protocols and BMR and BPR preparation.
• Making Sure that products are manufactured according to legal and Customer requirements.
• Diligently Verifies document Completion and Compliance.
Presentation on Establishing Quality Objectives
Top management shall ensure that quality objectives are established at relevant functions and levels within the organization. Quality objectives must be measurable and consistent with the quality policy. A quality objective aims for continual improvement and follows the SMART criteria of being specific, measurable, achievable, realistic, and time-bound. The steps to establish a quality objective include: 1) establishing a foundation based on quality policy and business objectives, 2) selecting key measurable parameters, 3) writing a quality objective statement focusing on improvement, 4) designing an implementation strategy, and 5) compiling and analyzing relevant data.
An overview of_quality_assurance_departm (2)
The quality assurance department in the pharmaceutical industry plays a key role in ensuring product quality and safety. It maintains oversight of production, quality control, warehousing, and facilities to ensure compliance with good manufacturing practices. The department is independent from production to provide unbiased quality monitoring. It utilizes tools like investigations, root cause analysis, change management, and quality reviews to continuously improve quality assurance. The overall goal is to protect public health by guaranteeing that medicines meet appropriate standards of identity, strength, purity and quality.
MacKeen, Robert
This document provides a summary of Robert L. MacKeen's qualifications and experience in quality assurance and supplier management roles spanning over 24 years. It highlights his expertise in establishing and maintaining compliance with ISO and FDA quality standards for medical devices, and roles leading quality assurance efforts at various companies. Key responsibilities included internal/supplier auditing, risk management, CAPA processes, and ensuring regulatory compliance.
Resume Maria Santana
Maria Santana Colon has over 15 years of experience in quality assurance roles within the pharmaceutical industry. She has a background in Lean Six Sigma methodology and has led teams that improved audit processes and reduced audit timeframes. Some of her responsibilities have included developing standards and metrics, performing investigations, revising standard operating procedures, and coordinating quality assurance activities like auditing materials and finished products. She currently works as a CSV/C Quality Auditor at Patheon, Inc., where she has also been involved in a Patheon Advantage project to develop the quality assurance and quality control departments.
Pfizer Sr. QC Scientist
Pfizer Sr. QC ScientistMaleeka Kazmi - Catalyst - Results Driven - PM Process Eng. Analytical Lab.Troubleshooting Expert
Maleeka Kazmi has over 10 years of experience in quality control and analytical testing for the pharmaceutical industry. She has a strong background in analytical techniques like HPLC, GC, and UV/Vis and experience with method development, validation and technology troubleshooting. Currently she works as a quality control scientist at Pfizer performing testing, audits and continuous improvement projects.Resume Lisa Claxton 12-11-15
Lisa Claxton has over 20 years of experience in quality management roles in regulated industries such as pharmaceutical manufacturing. She has worked in roles involving quality assurance, document control, training, auditing, and ensuring compliance with regulations. Her experience includes managing quality systems, developing training programs, approving product releases, and bringing facilities into compliance after regulatory issues.
Aims and objectives of quality control
This document is a proposal for an M.E. thesis on studying and analyzing product quality control. The proposal outlines introducing quality and quality control, aims of quality control like improvement and reduction of costs, the scope focusing on materials selection and quality control methods, an implementation plan to study theory and do case studies, and expected outcomes of improving product quality, productivity, and reducing costs.
Curriculum vitae
This document contains the resume of Hany Mohamed Gomaa. It details his work experience as a Senior Quality Assurance Manager and Management Representative at Marcyrl Pharmaceutical Industries since 2011, and previously as Quality Assurance Assistant Manager and Quality Auditing Departmental Head at the same company. It also lists his education and qualifications, including a Bachelor of Science degree in Chemistry from Ain-Shams University in Egypt.
Carmela 3-28-15
This document summarizes the qualifications and experience of Carmela Candi Coreschi as a Quality Assurance Manager, including over 30 years of experience in quality auditing, process improvement, and training. She has worked in quality roles for several companies, specializing in ensuring compliance and reducing defects. Coreschi has received recognition awards for her work and has a strong background in auditing, corrective actions, and maintaining quality standards.
Methods for quality management
This document discusses various quality management methods including acceptable quality level (AQL), benchmarking, cost benefit analysis, Deming wheel (PDCA), force analysis, Gannt chart, ISO 9000, Just in Time, Kaizen, potential problem analysis, problem prevention plan, quality circles, why how charting, zero defects, statistical process control, and Taguchi method. It provides the purpose, when to use, and benefits of each method. Examples of each method are also given.
Qc Vs Qa
Quality control focuses on fulfilling quality requirements by finding defects through techniques like testing and inspection, while quality assurance takes a more proactive approach through planned activities to prevent defects by analyzing processes, identifying areas for improvement, and ensuring proper training and tools are used. Quality assurance oversees quality control and looks at trends, audits processes, and provides feedback to help continuously improve quality.
GAINS Asia
Pallav Purohit presented on the Greenhouse Gas and Air Pollution Interactions and Synergies (GAINS) model, which is an extension of the Regional Air Pollution Information and Simulation model to also analyze greenhouse gases. GAINS has been implemented for 43 European countries and a GAINS-Asia project analyzing China and India is nearing completion. The GAINS model takes a multi-pollutant, multi-effect approach to quantify the health, environmental, and economic impacts of air pollutants and greenhouse gases and identify the most cost-effective emission control strategies to meet environmental targets.
Company Profile Pt Sani Mobil Indonesia 1
This document contains biographical information about an individual along with details about their professional experience and affiliations. It also outlines the vision, mission, services, and key advantages of the company PT. Sani Mobil Indonesia, where the individual serves as President Director. The company provides car rental, sales, and maintenance services and aims to become a top quality company in Indonesia and Asia by offering good products/services and customer satisfaction.
More Related Content
What's hot
Qa vs qc (yes)
QA is a set of proactive activities that focuses on processes to prevent defects by identifying weaknesses, while QC is a set of reactive activities that focuses on identifying and correcting defects in finished products. The goal of QA is to improve development processes so no defects arise, while the goal of QC is to identify defects after development before release.
Tugas qc vs qa fredy & andreas
This document compares and contrasts quality assurance and quality control. It defines quality control as focusing on fulfilling quality requirements through inspection and measurement, while quality assurance provides confidence that requirements will be fulfilled through planned and systematic activities. Quality control happens after work is completed and finds defects, while quality assurance prevents defects by focusing on processes and continuous improvement. The key difference is that quality control checks outputs, while quality assurance manages the system that creates the outputs.
Quality Assurance in Aviation
This was presented in a seminar organized by Pakistan Civil Aviation Authority on 9th Nov 2017 - World Quality Day
Case Study: Telecom Equipment Manufacturer Enhances QMS to Streamline Returns...
In order to meet increasing customer demand, a Fortune 500 Telecom Equipment Manufacturer added another remanufactured product line to their Special Customer Operations returns center. Spinnaker, who managed the client’s returns functions, was asked to provide more product processing; including testing and light manufacturing work. They were asked to evaluate the existing Digital Equipment Facility Testing (DEFT) lab protocols and product inspection processes to streamline operations and create new material workflows.
Importance of Quality Assurance
Here we discuss what Quality Assurance is as well as its benefits and the detriments associated with a lack of QA.
Kishor Ingale -QA
Kishor Ingale is seeking a senior level position in quality assurance with a reputable organization. He has over 30 years of experience implementing quality standards and systems to ensure regulatory compliance. Some of his core responsibilities include conducting audits, establishing quality procedures, and tracking non-conformances. He is skilled at identifying quality issues and recommending process improvements. Ingale holds an M.Sc. in Total Quality Management and has received additional training in areas such as auditing and six sigma. He is proficient in Microsoft Office applications.
Duties & Responsibilities of Quality Assurance Managers
Quality assurance managers play an important role in business by ensuring that products meet certain thresholds of acceptableness. They plan direct or coordinate quality assurance programs and formulate quality control policies. They also work to enhance an organization's efficiency and profitableness by reducing waste. If you're conscientious, inquisitive and committed to excellence, you'll realize it gratifying to work in this quality compliance occupation.
Design, standards and quality assurance
The document discusses quality assurance practices in aviation. It explains that aviation quality assurance systems monitor equipment, programs, and procedures to ensure Federal Aviation Administration standards are met. Key aviation quality assurance programs discussed include the Flight Operational Quality Assurance program and Aviation Safety Action Program, which analyze flight data to assess safety. Aircraft maintenance technicians are also subject to quality standards regarding inspections, maintenance, and repairs. The document outlines several primary aviation safety programs and notes that proper aircraft maintenance is essential for safety.
Cv | srinivas routhu | Quality Assurance | 10+ yrs experience
• Competent professional with 10+ years of experience in executing
In-process quality assurance by monitoring complete pharma
manufacturing process in order to comply with the specifications
• Over all responsible for IPQA Activities (both manufacturing and
packing area of solid orals, Nasal spray and Liquid dosage forms)
• Ensure the compliance of quality events like deviation
management, temporary change control, permanent change control, CAPA, Market complaints.etc.
• Active participation in root cause investigation and proposal of CAPA for deviation, market complaint and batch failure.
• Effectiveness check of implemented CAPA in shop floor.
• Calibration Management –ensure calibration of all IPQA instruments as per schedule.
• Skilled in preparation and review of Annual Product Quality Review (APQRs)
• Review of SOPs/work instructions-Gap identification and compliance of the same.
• Conducting in-house cGMP audits to ensure compliance and sound functioning of the process.
• Provide training regarding any changes to existing system and introduction of any new system.
• Knowledge on OOS, OOT, Site Master File.
• Hands-on experience in preparation of Process validations, cleaning validation, hold time study protocols and BMR and BPR preparation.
• Making Sure that products are manufactured according to legal and Customer requirements.
• Diligently Verifies document Completion and Compliance.
Presentation on Establishing Quality Objectives
Top management shall ensure that quality objectives are established at relevant functions and levels within the organization. Quality objectives must be measurable and consistent with the quality policy. A quality objective aims for continual improvement and follows the SMART criteria of being specific, measurable, achievable, realistic, and time-bound. The steps to establish a quality objective include: 1) establishing a foundation based on quality policy and business objectives, 2) selecting key measurable parameters, 3) writing a quality objective statement focusing on improvement, 4) designing an implementation strategy, and 5) compiling and analyzing relevant data.
An overview of_quality_assurance_departm (2)
The quality assurance department in the pharmaceutical industry plays a key role in ensuring product quality and safety. It maintains oversight of production, quality control, warehousing, and facilities to ensure compliance with good manufacturing practices. The department is independent from production to provide unbiased quality monitoring. It utilizes tools like investigations, root cause analysis, change management, and quality reviews to continuously improve quality assurance. The overall goal is to protect public health by guaranteeing that medicines meet appropriate standards of identity, strength, purity and quality.
MacKeen, Robert
This document provides a summary of Robert L. MacKeen's qualifications and experience in quality assurance and supplier management roles spanning over 24 years. It highlights his expertise in establishing and maintaining compliance with ISO and FDA quality standards for medical devices, and roles leading quality assurance efforts at various companies. Key responsibilities included internal/supplier auditing, risk management, CAPA processes, and ensuring regulatory compliance.
Resume Maria Santana
Maria Santana Colon has over 15 years of experience in quality assurance roles within the pharmaceutical industry. She has a background in Lean Six Sigma methodology and has led teams that improved audit processes and reduced audit timeframes. Some of her responsibilities have included developing standards and metrics, performing investigations, revising standard operating procedures, and coordinating quality assurance activities like auditing materials and finished products. She currently works as a CSV/C Quality Auditor at Patheon, Inc., where she has also been involved in a Patheon Advantage project to develop the quality assurance and quality control departments.
Pfizer Sr. QC Scientist
Pfizer Sr. QC ScientistMaleeka Kazmi - Catalyst - Results Driven - PM Process Eng. Analytical Lab.Troubleshooting Expert
Maleeka Kazmi has over 10 years of experience in quality control and analytical testing for the pharmaceutical industry. She has a strong background in analytical techniques like HPLC, GC, and UV/Vis and experience with method development, validation and technology troubleshooting. Currently she works as a quality control scientist at Pfizer performing testing, audits and continuous improvement projects.Resume Lisa Claxton 12-11-15
Lisa Claxton has over 20 years of experience in quality management roles in regulated industries such as pharmaceutical manufacturing. She has worked in roles involving quality assurance, document control, training, auditing, and ensuring compliance with regulations. Her experience includes managing quality systems, developing training programs, approving product releases, and bringing facilities into compliance after regulatory issues.
Aims and objectives of quality control
This document is a proposal for an M.E. thesis on studying and analyzing product quality control. The proposal outlines introducing quality and quality control, aims of quality control like improvement and reduction of costs, the scope focusing on materials selection and quality control methods, an implementation plan to study theory and do case studies, and expected outcomes of improving product quality, productivity, and reducing costs.
Curriculum vitae
This document contains the resume of Hany Mohamed Gomaa. It details his work experience as a Senior Quality Assurance Manager and Management Representative at Marcyrl Pharmaceutical Industries since 2011, and previously as Quality Assurance Assistant Manager and Quality Auditing Departmental Head at the same company. It also lists his education and qualifications, including a Bachelor of Science degree in Chemistry from Ain-Shams University in Egypt.
Carmela 3-28-15
This document summarizes the qualifications and experience of Carmela Candi Coreschi as a Quality Assurance Manager, including over 30 years of experience in quality auditing, process improvement, and training. She has worked in quality roles for several companies, specializing in ensuring compliance and reducing defects. Coreschi has received recognition awards for her work and has a strong background in auditing, corrective actions, and maintaining quality standards.
Methods for quality management
This document discusses various quality management methods including acceptable quality level (AQL), benchmarking, cost benefit analysis, Deming wheel (PDCA), force analysis, Gannt chart, ISO 9000, Just in Time, Kaizen, potential problem analysis, problem prevention plan, quality circles, why how charting, zero defects, statistical process control, and Taguchi method. It provides the purpose, when to use, and benefits of each method. Examples of each method are also given.
Qc Vs Qa
Quality control focuses on fulfilling quality requirements by finding defects through techniques like testing and inspection, while quality assurance takes a more proactive approach through planned activities to prevent defects by analyzing processes, identifying areas for improvement, and ensuring proper training and tools are used. Quality assurance oversees quality control and looks at trends, audits processes, and provides feedback to help continuously improve quality.
What's hot (20)
Case Study: Telecom Equipment Manufacturer Enhances QMS to Streamline Returns...
Case Study: Telecom Equipment Manufacturer Enhances QMS to Streamline Returns...
Duties & Responsibilities of Quality Assurance Managers
Duties & Responsibilities of Quality Assurance Managers
Cv | srinivas routhu | Quality Assurance | 10+ yrs experience
Cv | srinivas routhu | Quality Assurance | 10+ yrs experience
Viewers also liked
GAINS Asia
Pallav Purohit presented on the Greenhouse Gas and Air Pollution Interactions and Synergies (GAINS) model, which is an extension of the Regional Air Pollution Information and Simulation model to also analyze greenhouse gases. GAINS has been implemented for 43 European countries and a GAINS-Asia project analyzing China and India is nearing completion. The GAINS model takes a multi-pollutant, multi-effect approach to quantify the health, environmental, and economic impacts of air pollutants and greenhouse gases and identify the most cost-effective emission control strategies to meet environmental targets.
Company Profile Pt Sani Mobil Indonesia 1
This document contains biographical information about an individual along with details about their professional experience and affiliations. It also outlines the vision, mission, services, and key advantages of the company PT. Sani Mobil Indonesia, where the individual serves as President Director. The company provides car rental, sales, and maintenance services and aims to become a top quality company in Indonesia and Asia by offering good products/services and customer satisfaction.
Electronics
This document provides an overview of electronics concepts including:
- Basic definitions of current, voltage, and resistance according to Ohm's Law.
- Components such as resistors, capacitors, inductors, diodes, transistors, and operational amplifiers.
- Sensor fundamentals and transducers that convert physical quantities to electrical signals.
- Interfacing sensors to the Handy Board and concepts related to digital and analog signals, sampling, quantization, and filtering.
GogginbeyonddigitaldividetalkPPDD2015ScotsdaleAZ
Beyond Digital Divides in Asia, Oceania, Middle East & Africa, talk for Partnership for Progress on Digital Divide 2015 conference, ASU Scotsdale, AZ, 21-22 Oct 2015
Cd mability of off grid electrification projects
This document discusses off-grid electrification projects under the Clean Development Mechanism (CDM). It notes that while over 1.4 billion people globally lack access to electricity, off-grid electrification projects are rare in the CDM project pipeline. The document outlines key terms and statistics related to the CDM and finds that Programmes of Activity (PoA) could help promote more off-grid electrification projects by providing flexibility and lowering transaction costs. In summary, the CDM has failed to fully deliver promised development benefits for rural areas, and a post-2012 framework along with greater use of PoAs may help support more off-grid renewable energy projects.
Agesta 2015 av Ingemar Pongratz
Av Ingemar Pongratz,
Bilder från en promenad med tillhörande svampplockning med Elma, Lia och dom. Vi tog en trip runt Ågesta denna gång.
Vi hittade OK med svamp och en del blåbär som blev uppätna på väg hem...
Mer om Ingemar Pongratz på:
https://about.me/ingemar.pongratz
JIU Trasncript 3-14-2012
This unofficial transcript is for Rebecca Jett, enrolled in the Bachelor of Business Administration program at Jones International University. It shows her coursework and grades over multiple terms from transfers of credits and courses completed at Jones International University. She maintained a cumulative GPA of 3.58 and earned her Bachelor of Business Administration degree in February 2011 with an Accounting concentration, graduating Cum Laude.
Flexibility Instruments of the Kyoto Protocol
The document summarizes the Kyoto Protocol's flexibility mechanisms, including the Clean Development Mechanism (CDM). It outlines emissions targets for countries, describes how the CDM works to generate carbon credits from emissions reduction projects in developing countries, and reviews CDM project statistics. Over 3000 CDM projects have been proposed, with over 2.7 billion credits expected. Registered projects have generated over 188 million credits so far. The CDM aims to lower compliance costs and drive sustainable development, but has also faced criticisms around additionality and effects on national strategies.
Le calendrier éditorial, outil essentiel pour gérer ses publications Facebook
Être présent sur les réseaux sociaux est un atout pour une entreprise. Encore faut-il les utiliser de manière pertinente : posts réguliers, adaptés et variés. Pensez au calendrier éditorial ! Cet outil vous permet d’optimiser la gestion de votre compte Facebook. Grâce à son utilisation, vous pourrez aisément organiser la fréquence et le type de vos publications.
Quantas Instruções por Ciclo?
Palestrante: Luiz Carlos Orsoni - MAFFEI
A partir das z990 (T-Rex, em 2.003), os Mainframes da Série z passaram a ser Super Escalares, ou seja, capazes de executar mais de uma Instrução por Ciclo. Embora sejam indiscutivelmente capazes, isto não significa que sempre executarão mais do que uma Instrução por Ciclo, podendo não executar nenhuma! Como já enfatizamos em vezes anteriores, isto é extremamente dependente da qualidade do Software e de outras atividades que ocorram simultaneamente nos CECs. Esta palestra procurará aclarar os conceitos envolvidos, tendo como exemplos os detalhes internos das z13, capazes de executar até dez Instruções por Ciclo.
Portrait drawing
Drawing a portrait starts with the basic shapes of the head - an oval or circle shape for the skull, a circle for the face, and lines to mark the features. The eyes, nose, and mouth are drawn as simple shapes to establish their placement within the face shape. Details like eyebrows and hair are added last to complete the likeness.
186144-196277-13-PB
1) Critical pedagogy currently exists precariously and marginally in education, similar to a shabby addition to a typical American house, where critical educators are as rare as "hen's teeth".
2) The article discusses how capitalism has become a global system dominated by a transnational capitalist class that exploits workers and exacerbates inequality.
3) Revolutionary critical pedagogy seeks to challenge this system and push for greater democracy in schools, but faces significant marginalization and obstacles.
Viewers also liked (14)
Le calendrier éditorial, outil essentiel pour gérer ses publications Facebook
Le calendrier éditorial, outil essentiel pour gérer ses publications Facebook
Similar to Resume Keay Wu
Ramesh Javali.cv
Ramesh Javali is an experienced Quality Assurance and Quality Control professional seeking a leadership role in the pharmaceutical sector. He has over 25 years of experience managing QA/QC functions and teams, ensuring compliance with regulatory standards. Some of his responsibilities have included method validation, stability testing, audits, and maintaining quality control of raw materials, processes, and finished products. He is skilled in analytical techniques, quality systems, and developing QA/QC teams.
QC QA VALIDATION.pptx
This document discusses quality control, quality assurance, and validation processes in pharmaceutical manufacturing. It defines key terms like QA, QC, cGMP, and describes the three stages of process validation. Quality systems help ensure safety and effectiveness through management responsibilities, resources, manufacturing operations, and evaluation activities. Adhering to cGMP regulations and maintaining a robust quality system leads to consistent production of quality products.
Ray Hopkinson Resume Feb 15_2015
Raymond Hopkinson has over 20 years of experience in quality assurance roles across various industries including engineering, food processing, chemicals manufacturing, and plastics. He is currently the Quality Systems Lead for an engineering company, where he develops and implements quality plans and inspection test plans to ensure compliance. Previously he held roles as Quality Assurance Coordinator and ISO Auditor for other companies. He has a diploma in Chemical Technology and a degree in Chemistry.
Hazar analisys points
This document provides an overview of quality assurance (QA) and hazard analysis critical control points (HACCP) programs in the food industry. It discusses the importance of QA programs for food safety and profitability. QA programs monitor all aspects of food production, from raw materials to finished products. The key components of an effective QA program include clear objectives, inspection procedures, product standards, testing protocols, and record keeping. HACCP is a seven step process for identifying and controlling food safety hazards. Effective QA programs require management support, dedicated staff, and defined roles and responsibilities.
Vipul Patel
Vipul Patel has over 20 years of experience in pharmaceutical quality control and laboratory management. He is currently an Associate Director of Laboratory Operations at Sun Pharmaceutical Industries in Detroit, Michigan, where he oversees quality control, analytical development, stability testing, and other laboratory functions. Patel has extensive experience ensuring regulatory compliance, leading inspections, and driving continuous improvement in laboratory operations.
Resume Huff_Jamie__Thermo Fisher 2016
Jamison C. Huff has over 20 years of experience in operations management, quality systems, and continuous improvement. He is currently the Quality Systems Supervisor at Thermo Fisher Scientific where he implements and maintains quality systems and ensures regulatory compliance. Previously he held plant manager and operations manager roles at various beverage manufacturing companies where he improved processes, reduced costs, and ensured safety and quality standards. He served in the United States Marine Corps for over 4 years in various leadership roles.
Process Validation for Drugs and Biologics
This training course provides an understanding of process validation requirements for pharmaceutical and biologic products. Participants will learn how to establish effective process validation systems and integrate them with other quality systems. They will also learn how to develop validation protocols and reports, as well as monitoring programs, to ensure critical process parameters remain in control. The course reviews validation needs for electronic systems and covers the FDA's process validation lifecycle approach.
resume
The document provides a summary of Joseph E. Mack Jr.'s qualifications for a Quality Assurance position. He has over 10 years of experience in Quality Assurance and Quality Control, including being a Certified Quality Auditor. He has extensive knowledge of cGMP regulations and experience auditing both internal and external processes. Currently he is the GMP QA Manager at Cambridge Isotope Laboratories where he oversees the Quality System and ensures compliance.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas Andalas
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
RESUME BP OCT16
Brian Pickering has over 15 years of experience in microbiology quality control and assurance roles within the biologics manufacturing industry. His experience includes establishing environmental and raw materials monitoring programs, training personnel, managing microbiology laboratories, ensuring compliance with regulations, and representing companies in regulatory audits and responses. He currently serves as the QC Raw Materials Microbiology Manager at Sanofi Genzyme in Northborough, MA where he manages various microbiology and contamination control programs.
Mohammas shakarnah CV (2)
Mohammad Ibrahim Shakarnah is seeking an advanced managerial role in food quality assurance and control. He has over 6 years of experience in food quality control and assurance at Siniora Food Industry, where he currently serves as Quality Assurance and Control Supervisor. In this role, he oversees quality inspection and control, implements various food safety systems, and ensures compliance with regulations. Mohammad aims to leverage his proven leadership and technical skills to further his career in ensuring food safety and quality.
revised resume 2014
Charlotte McIlvaine has over 20 years of experience in quality assurance and analytical chemistry roles within the pharmaceutical industry. She has a proven track record of leading quality assurance operations, implementing new quality systems, resolving issues, and ensuring compliance. Her background includes managing QA teams, developing standard operating procedures, performing audits, and overseeing manufacturing and distribution operations. She currently holds the role of Quality Assurance Manager and has transformed QA programs and launched new products at multiple companies.
CVAjusino2015
Angel Mario Jusino Berrios is an experienced registered pharmacist with extensive experience in the pharmaceutical industry, managing consent decrees and ensuring regulatory compliance. He has held senior roles providing quality consulting services, including implementation of validation guidelines, quality system assessments, and preparation of regulatory reports. Berrios has expertise in areas such as quality system implementation, process validation, remediation programs, auditing, and technical strategies.
Quality Management System by Signorina Y. Bueno (WMSU-ZC)
This document discusses quality assurance theories and applications. It describes the roles and responsibilities of a quality assurance department. Key points include:
- QA's role is to evaluate and advise on a company's quality program, not be responsible for quality control operations.
- QA should report directly to top management to maintain independence.
- A QA program consists of quality control, evaluation, and auditing functions.
- QA personnel monitor compliance, procedures, records, issues, and ensure quality at all stages of production.
- The vice president of QA is responsible for quality policies, programs, and leadership and acts as an advisor to top management on quality matters.
Ben Wade 2017 Resume
Benjamin R. Wade has over 15 years of experience in quality control and quality assurance, including managing teams and projects at Emergent BioSolutions. He has a strong technical background in analytical testing and method development and validation. Currently, Wade is the founder and Chief Brewing Officer of Albion Malleable Brewing Co., where he oversees all aspects of launching and operating the brewery.
Karen cash resume_qc08262017
This summary provides an overview of Karen Cash's 20+ years of experience in quality roles in the biotech industry:
- She has extensive experience in quality assurance, quality control testing, process improvements, and complaint investigations for biotech and medical device companies.
- Her most recent role was as a Quality Assurance Scientist investigating complaints at Beckman Coulter, where she analyzed data to determine causes and ensure compliance.
- She is looking to transfer her quality skills to the medical device industry in the Minneapolis area, having recently relocated from Wisconsin.
quality_management_plan_4108_ppt_final.pptx
This document provides a quality management plan template for a project to expand a company's retail operations into physical stores. The template includes sections for an introduction, quality objectives, roles and responsibilities, quality assurance activities, quality control measures, change management, quality improvement, documentation, reasons for using the template, constraints, and references. The quality objectives are to meet customer expectations, deliver a high-quality store aligned with brand standards, minimize defects and rework, and continually improve deliverables. Roles defined include a project manager, quality assurance team, and project team members. Quality assurance activities cover planning, control, and documentation. Quality control measures include inspections, testing, and supplier management.
quality_management_plan_4108 ppt final.pptx
This document provides a quality management plan template for a project to expand a company's retail operations into physical stores. The template includes sections for an introduction, quality objectives, roles and responsibilities, quality assurance activities, quality control measures, change management, quality improvement, documentation, reasons for using the template, constraints, and references. The quality objectives are to meet customer expectations, deliver a high-quality store aligned with brand standards, minimize defects and rework, and continually improve deliverables. Roles defined include a project manager, quality assurance team, and project team members. Quality assurance activities cover planning, control, and documentation. Quality control measures include inspections, testing, and supplier management.
Resume Kevin_Koski_August_2016
Kevin P. Koski has over 21 years of experience in project leadership, process engineering, product development, manufacturing, quality control, and project management in the pharmaceutical and medical device industries. He currently works as a Senior Manager of Manufacturing Technical Support at Roche Carolina Inc., where he leads technical support projects and quality initiatives. Previously he held roles in process development, engineering, and operations at Talecris Biotherapeutics, Bayer Healthcare, and Grifols Therapeutics. He has extensive expertise in all stages of product development and manufacturing processes.
resume.Timothy.L.Sunderland
Timothy L. Sunderland has over 21 years of experience in validation and quality assurance for the pharmaceutical and biotechnology industries. He has extensive experience managing validation projects, authoring protocols, executing qualifications, and writing summary reports. His areas of expertise include cGMP regulations, equipment and process qualifications, aseptic manufacturing, and environmental monitoring. He is proficient in project management, regulatory compliance, and computer systems.
Similar to Resume Keay Wu (20)
GMP & Quality Assurance Training by Fakultas Farmasi Universitas Andalas
GMP & Quality Assurance Training by Fakultas Farmasi Universitas Andalas
Quality Management System by Signorina Y. Bueno (WMSU-ZC)
Quality Management System by Signorina Y. Bueno (WMSU-ZC)
Resume Keay Wu
- 1. Keay Wu (510) 266-2743 Keaywu18@gmail.com HIGHLIGHTS • Quality Control/Quality Assurance professional with over 20 years in biopharmaceuticals. • Managed a staff of 30+ employees supporting a 24/7 GMP manufacturing operation. • Proven leader with emphasis in Quality Control Environmental Monitoring (QCEM). • Remediated the QCEM program at the Chiron Liverpool facility during the vaccine shortage. • Spearheaded consolidation of 2 business units after a departmental merger and maintained a 98% retention rate. • Strong command of licensed GMP manufacturing facilities and associated utilities, including Purified Water, Water for Injection, Clean Steam and compressed gas systems. • Excel at coaching, mentoring, developing and maximizing talent. • Thrive on establishing and maintaining productive working relationships with colleagues and cross-functional teams throughout the organization. • Led QC effort during corporate spin-off by consolidating laboratory operations and revising 30+ standard operating procedures resulting in a workload reduction of 40%. • Managed the building of a new QC Chemistry laboratory, relocating and validating equipment, on time and on budget. • Successfully implemented Baxalta GO2020 initiative within the QC department and communicated new corporate vision to staff to navigate organizational changes effectively. EXPERIENCE QUALITY CONTROL SENIOR MANAGER 2014-Present Baxalta Inc. Hayward, CA • Oversee QC Microbiology, Chemistry and Immunology laboratory functions with a team of 20 employees. • Represent QC Department at senior cross-functional staff meetings, including Management Trend Review, Project Prioritization, Change Management, Discrepancy Resolution, and Capital Planning. • Represent QC at strategic planning sessions to prepare the site to produce phase I/II clinical product as a pilot plant facility. • Manage Long Term Service Agreement to provide microbiological laboratory customer support to Baxter HealthCare. • Facility Sterility Assurance representative for the Hayward site responsible for the implementation of the Microbial Contamination Control Program.
- 2. QUALITY ASSURANCE SENIOR MANAGER 2008-2013 Bayer HealthCare Emeryville, CA • Environmental Quality Assurance (EQA) Manager responsible for providing quality oversight for the Emeryville Supply Center. • Managed the airflow visualization program to ensure all aseptic manufacturing suites adhere to the highest quality air standards as defined by regulatory guidance. • Acted as Subject Matter Expert (SME) for change controls pertaining to GMP manufacturing facilities and associated utilities to ensure compliance of validation systems. • Performed Quality review and approval of QA/Engineering/Validation documents, including Trend Reviews, Risk Assessments, Project Execution Plans, User Requirement Specifications, Validation Protocols and Reports. • Reviewed and performed disposition of discrepancy investigations, on average 50 per year, related to facilities and GMP manufacturing operations. QUALITY CONTROL MANAGER 1992-2008 Chiron/Novartis/Bayer HealthCare Emeryville, CA • Represented the corporate QCEM function during internal, partner and regulatory inspections (by health authorities from: US, Europe, Canada, Mexico, Brazil, UK, Japan, etc.) occurring, on average, 2-3 times per year. • Managed QCEM department providing support to the Emeryville Supply Center. • Consolidated the Chiron Blood Testing and Biopharmaceutical business units to form a corporate QCEM department of 30 employees. • Implemented quality modules and corporate directives after company acquisitions by Novartis Corporation and Bayer HealthCare. • Provided QCEM support to large scale commercial manufacturing processes including fermentation, purification/formulation and aseptic processing operations. • Led QCEM effort in conjunction with complex annual preventive maintenance shutdown activities, facility/utility modifications and new systems implementation resulting in on- time release and start-up of licensed manufacturing facilities. • Presented QCEM summary at weekly manufacturing operations and quarterly commercial product trend review meetings. EDUCATION B.S. Biological Sciences: Concentration in Microbiology San Francisco State University