Sandra Perryman has over 10 years of experience in quality assurance and food safety. She holds an MPH and has managed quality assurance and food safety programs for several large food companies. Her experience includes implementing food safety systems, conducting audits, ensuring regulatory compliance, and new product development.
An IRCA certified Lead Auditor of the Food Safety Management System, heading the QA functions & Hygiene with overall 19 years experience in Aviation/ in-flight Catering. Expertise in Six Sigma, Food Safety & Hygiene Audits, Medina QSAI Food Safety & Quality Validation Audits with exposure of International Airlines inflight Catering experiences.
I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.
An IRCA certified Lead Auditor of the Food Safety Management System, heading the QA functions & Hygiene with overall 19 years experience in Aviation/ in-flight Catering. Expertise in Six Sigma, Food Safety & Hygiene Audits, Medina QSAI Food Safety & Quality Validation Audits with exposure of International Airlines inflight Catering experiences.
I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.
Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
• 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.
Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems,
Manish Kumar, B.sc-with Microbiology, chemistry, Diploma in dairy Technology.
Having 7 year Experience in Quality assurance in Food & Beverages (snacks, Tea, Water, Juices, Process food, staple foods- spices, flour, Oil and fats).Currently working with TATA global beverage ltd (TATA TEA LTD) in Tea manufacturing plant, handing Quality team. Handling Documentation part like-SOP preparation, change control, deviation control, process validation, IQ, PQ, OQ, System validation, Internal and external audit, Glass policy, Root cause analysis, CAPA, Trainings on GMP, Food safety, PRP, OPRP, HACCP, FSMS, 5S, Pest control management, customer complaint handling, Implementation of FSSAI norms, New product development, R&D in process and staples foods, Vendor management, Regulatory requirements as per FSSAI etc. Handled Microbiological, Analytical testing & Packing Exp, pasteurisation, homogenization, Fumigation in food and dairy industry, Handling team 20 Persons, sensory evolution of food products, SAP software handling, Yellow belt in lean six sigma.
Dairy experience- standardization of milk, pasteurization, homogenization, poly pack of full cream, tond, double tond milk, yogurt, spry drying milk power , nutritional protein powder, Ice-cream manufacturing.
Position Summary:
Responsible for developing, implementing and managing systems to mitigate the risk of experiencing unacceptable levels of bioburden in products. This includes establishing best practices, process controls and environmental monitoring programs that reduce the potential for microbial product contamination. Also responsible for training manufacturing associates on aseptic technique and monitoring and coaching production associates at their work stations.
Key Responsibilities:
•Microbial sampling, identification & bioburden mapping of production facilities.
•Bioburden challenge studies for existing and new product formulations.
•Bioburden risk assessment and validation for new product development process.
•Aseptic process development and process control.
•Environmental and water monitoring of Rockford and Wisconsin sites.
•Interpret test results and initiate corrective actions as needed.
•Assist with equipment and process cleaning validations.
•Clean room management inclusive of mentoring and supervising 23 clean room associates.
•Microbial test-method development as per USP test method suitability.
•Contamination investigations & implementation of corrective actions.
•Prepare reports and present data with conclusions.
•Maintain microbiology laboratory equipment and supplies.
Also efficiently performed Preservative Efficacy Challenge Tests, Environmental monitoring, LAL Endotoxin testing (Kinetic & Gel Clot methods), Microbial Ingress Integrity Testing (both Dye Penetration & Bacterial Challenge testing), Microbial Identification using Biolog, Mycoplasma testing of products using Luminometer, Bioburden & Water testing.