VISHNU_Resume_01
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Vishnu Verma is seeking a job as an integral part of a result-oriented pharmaceutical team where he can utilize his knowledge and experience. He has over 6 years of experience in quality assurance and analytical roles at various companies including Zydus Cadila Healthcare, Aurobindo Pharma, and Glenmark Generics. His responsibilities have included reviewing analytical data, stability protocols, audits, change controls and more. He holds an M.Pharm degree and has experience with instrumentation, software, and computer skills relevant to the industry.
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Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.
NM CV 041114
The document provides a summary of Nikhil Mahajan's qualifications and experience seeking a role in quality management. It outlines his past work experience spanning over 15 years in quality assurance and systems roles at various automotive companies. It also lists his responsibilities in areas like new product development, supplier quality, quality systems, audits, and projects. His academic credentials include an MBA and BTech in Mechanical Engineering. Contact details and a profile outline are also included.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
CVQC_SP
The document provides a summary of an individual's experience in quality control and analytical roles in the pharmaceutical industry spanning over 11 years. It includes experience managing quality control testing, method development and validation, documentation, audits, and ensuring compliance with regulatory standards. The individual holds an M.Sc. in Chemistry and has worked in quality control laboratories for several major pharmaceutical companies in India and Oman, taking on roles of increasing responsibility including group leader and assistant manager.
Hitesh maheshbhai patel
Hitesh Patel has over 5 years of experience in the pharmaceutical industry working in quality assurance and quality control roles. He holds a B.Pharm degree from Rajiv Gandhi University of Health Sciences in Bangalore and an M.S. degree from the University of Greenwich in the UK. Currently he works as a Senior Officer in quality assurance at Intas Pharmaceuticals Ltd. He has experience with validation, documentation, complaint handling, and regulatory audits. His professional skills include Microsoft Office, communication, and familiarity with SAP systems.
Hitesh maheshbhai patel
working in Quality assurance department in Qualification and validation department.
involve in new equipment qualification like multi connected tank ( Skid).
involve in media fill activity and investigation.
involve in qualification of HVAC.
involve in new facility startup activity.
Hassan Haider Siddiqui CV.pdf
This document contains the resume of Hassan Haider Siddiqui. It includes his personal details like name, date of birth, address and contact information. It outlines his objective of pursuing a challenging career. His professional experience includes current and previous roles in quality control and R&D at pharmaceutical companies. Responsibilities included supervising validation studies, analytical method development and testing. The document also lists his educational qualifications and certifications obtained, as well as achievements and personal skills.
Kapil CV_4.5 years exp in QA@Mylan
Kapilraj Bharat Gudala is seeking a challenging position in quality assurance and management. He has over 4.5 years of experience in roles such as quality control officer and QA compliance executive at Mylan Laboratories Ltd. in Nashik, India. His responsibilities have included performing and reviewing annual product reviews, investigating customer complaints, conducting root cause analyses, and initiating corrective and preventive actions. He is proficient in various computer systems including TrackWise, SAP, LIMS, Minitab and Empower.
Update CV
This document is a CV for an applicant named Krushnakant Maheshkumar Soneji applying for the position of Manager Quality Control. The 3-page CV provides details on his educational background, past work experience in quality control roles at several pharmaceutical companies, and describes the key responsibilities and functions of a Manager Quality Control position such as planning, quality management, analysis and calibration, documentation review, and team building. The applicant's expected salary is listed as negotiable.
Ranjeet resume (1)
Deputy Manager QA, working exp in beverage, juice water , sauces ketchup, mayonnaise and Jam & new product development. FSMS , HACCP & FSSC implementation& auditing
Vikas_gupta
Vikas Gupta is seeking a career opportunity in a leading corporate environment. He has an Associate Examination in Chemistry from Institution of Chemist Kolkatta, a Diploma in Business Management from ICFAI University, and a Bachelor in Pharmacy from Punjab Technical University Jalandhar Punjab. He has over 5 years of experience in quality assurance roles at various pharmaceutical companies including Lupin Ltd and Regional Drugs Testing Laboratory. His responsibilities included review of samples, audits, and ensuring quality compliance. He has expertise in laboratory software and has received an award for his performance in an analytical instruments training program.
MURTHY RESUME
P. Murthy Raju is a Production Officer with over 8 years of experience in the pharmaceutical industry. He is looking for a challenging position in manufacturing that allows him to grow professionally. He has a MSc in Chemistry and has worked at Mylan Laboratories and Divis Laboratories. Some of his responsibilities include production planning, supervision, achieving targets, ensuring quality, technology transfer, process improvements, audits, and safety training. He has knowledge of SAP, process validation, cGMP guidelines, troubleshooting, and change control. He aims to contribute to organizational goals through his technical and communication skills.
Kiran Kumar M
Kiran Kumar is a senior manager at Aurobindo Pharma with over 16 years of experience in quality assurance. He leads a team that reviews quality control data and provides analytical assurance. Previously, he worked at Mylan Laboratories as manager of quality control assurance, auditing contract manufacturing units. Kiran holds an MSc in Pharmaceutical Chemistry and BS in Botany, Zoology, and Chemistry. He has validated over 210 analytical methods, audited over 100 firms, and faced regulatory inspections from agencies like USFDA.
Similar to VISHNU_Resume_01 (20)
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...
VISHNU_Resume_01
- 1. RESUME VISHNU VERMA Present Address - 58/305,Anandnagar, Society, Anandnagar Road, Vejalpur Ahmedabad Mobile: 8866199128, 9584467559 E-mail: vws.company@gmail.com JOB OBJECTIVE To be an integral part of result oriented team of dedicated professionals that will utilize and enhance my knowledge, skill and professional experience for mutual growth of Pharma Industry. INDUSTRIAL EXPERIENCE Current Organization:- Organization: - Zydus Cadila Healthcare Ltd. Ahmedabad Department :- Corporate Quality Assurance ( Analytical Assurance) Duration :- Aug- 2015 to till. Designation :- Sr. Executive JOB RESPOSIBILITY Support to various site for the LIMS implementation in the Zydus Cadila Healthcare. Support to various site for the Chromeleon implementation in the Zydus Cadila Healthcare. Review of Specification for Raw material, Packing Material, Finish product and stability. Review of Analytical data for RM, PM, FP and Stability at the different site. Review of Incident, Deviation and Change Control related to QC for different site of Zydus Cadila Healthcare. Review of Stability Protocol, Hold time study sheet and Stability Summary sheet before regulatory Submission. Approval of change control and specification. Review of OOS, OOT and tracking of CAPA for different site. Review of final APQR for different site of Zydus Cadila Healthcare Ltd. Conducting audit for the different sites of Zydus Cadila Healthcare and vendor. To submit the product for the filling to various agency for different site of Zydus Cadila. Prepare the sites for the Audits (USFDA, WHO, MHRA, PICS).
- 2. Gape assessment between Quality Policies and Plant SOPs, prepare the Quality Policies. To Review of analytical data of Exhibit Batch before Regulatory Submission. PREVIOUS EXPERIENCE Organization : - Aurobindo Pharma Ltd. Unit-III Hyderabad (T.S.) Department :- (LAB COMPLIANCE GROUP) Independent Data Reviewer Duration :- Feb- 2015 to Aug-2015 ( 6- Month) Designation :- Executive. JOB RESPOSIBILITY Responsible for collection of sample details from LIMS of respective site. Responsible for review of Finish Product and In process analytical data. Review of Stability Study Protocol and Stability Summary Sheet. Responsible for review of Electronic analytical data related to various types of samples received in Quality Control /Analytical Laboratory this Includes: Electronic Data , printed data and log books, Responsible for review of system Audit Trials, LIMS entries. Like Finish, In-process, Stability, RM, and Tech-Transfer. Responsible for review of deleted data in Empower. Review of OOS and OOT and PNC ( Incident) related to QC. Review of Master SOPs of QC and QA. Responsible for initiating and Evaluation of process nonconformance (Incident) inQMS. Organization: - Glenmark-Generics Ltd. Pithampur Indore (M.P.) Department :- Analytical Assurance ( AQA) & QC Duration :- Dec - 2011 to Jan – 2015 ( 3.1 Year) Designation :- Officer JOB RESPOSIBILITY Review Analytical Report of Raw material, Packing Material, Finished product, In process Material, Process validation, Method Validation, Cleaning Validation, , Technology Transfer, , Swab, Water and Stability Products etc. Final batch release activity in SAP. Preparation of Hold time summary report & Master Hold time list. Review of stability protocol & stability summary report. Review & approval of Specs/STP/GTP. Review of Method validation & cleaning validation protocol & report Preparation and Approval of Technology Transfer protocol.
- 3. Analytical Data submission to Regulatory for ANDA Submission. Handling of Incidences, Deviation, OOS and OOT and their Tracking. Tracking & review of Conditional release material. Review & Tracking of Change control of QC dept. ACTIVE MEMBER IN AUDIT USFDA, WHO, MHRA, PICS ACADEMIC QUALIFICATION Qualification Institute University/Board Year of Qualification Percentage M. Pharm S.R.M University Chennai S.R.M University Chennai 2009-2011 72.5% B. Pharm R.K.D.F. College of Pharmacy Bhopal R.G.P.V. Bhopal 2005-2009 65.4% Computer Diploma National Institute Bhopal National Institute Bhopal 2008 72.0 % H.S.C. Govt. Boys. Higher Secondary School Ashta M.P. Board 2004 76.0 % S.S.C. Govt. Boys. Higher Secondary School Maina M.P. Board 2002 60.0% INSTRUMENT EXPERIENCE High Performance Liquid Cinematography (Make: Waters) Empower software-2 U.V. & Visible Spectrophotometer. [Make: Perkin Elmer] Dissolution Test Apparatus. USP ( Elactrolab) Karl Fisher Titration SOFTWARE EXPERIENCE Having Experience of SAP. LIMS, Documentum Software (DMS). MINI TAB SOFTWARE. Batch Release Activity in SAP. AREA OF INTEREST Analytical Quality Assurance, QMS, CQA COMPUTER SKILLS Basic Knowledge: MS DOS, WINDOWS, EXCEL.
- 4. PERSONAL PROFILE Name : Vishnu Verma Father’s Name : Laxminarayan Verma D.O.B : 09/10/1986 Marital Status : Married Sex : Male Nationality : Indian Language Name : Hindi, English Permanent Add. :Sai-Villa Apartment Flat no 402 Shiv City Indore(M.P.) Mobile No. : 8866199128, 09584467559 DECLARATION I do hereby declare that all information mentioned above is true to the best of my knowledge and belief. DATE : PLACE : VISHNU VERMA