Mayur Prajapati
Winnipeg,Canada
Summary
Professional with over 11 years of QA experience in Oral solid dosage forms and Sterile dosage forms for Health Canada, US-FDA, MHRA and TGA approved pharmaceutical industries. Experience in aseptic processing, sterile manufacturing and relevant process and facility controls. Having responsibility for plant quality systems, problem solver and detailed oriented. Fully understand the importance of compliance. Results driven, focused on achieving success and increased productivity through improvements in operations, Quality, and safety.
Overview
11
11
years of professional experience
Work History
QA Reviewer II
IVC VITA HEALTH
Winnipeg, Canada
04.2022 - Current
- Conduct verifications on the documentation associated with received raw material, printed and non-printed packaging components
- Conduct reviews on executed batch records and QC Laboratory records and all associated documentation Verify that Production and QC documentation are completed in compliance with approved SOPs
- Ensure changes/ deviations in production or quality control have been approved according to QMS.
- Identify, report and resolve identified discrepancies and non-conformances.
- Initiate deviations, provide directions for any corrective actions that are required and complete any related tasks assigned.
- Verify the lot meets the release requirements are met for a release decision.
- Conduct the ERP system (M2M) transactions for the release of the lots.
- Collaborate with Product Owners, Developers and other QA team members as required on Acceptance criteria that need to be tested.
- Compile release documentation for customers (Certificate of Analysis, Certificate of Manufacture and Certificate of Packaging) and provide to both internal and external customers.
- Immediately notify Supervisor or manager upon detection of a non-conformance.
- To take immediate corrective actions, where possible, which may include to stop/prevent the continuation of the incident/deviation.
- To initiate deviation in SOLABS and submitted for QA Assessment within one (1) business day of identification of the incident.
- To provide Subject Matter Expertise (SME) to assist in the investigation process.
QA Associate
Genvion Corporation
Winnipeg, Canada
12.2019 - 04.2022
- Review and release of executed batch records To verify that the manufacturing records are complete, all in-process labels and equipment cleaning labels are accounted, calculations and reconciliations are complete.
- To verify the dispensed materials weighing matches to the dispensing labels and printouts from balances and scales.
- To verify that in process test results and finished product QC test results are released and met acceptance criteria.
- To verify all calculations, reconciliation and yields are within specification.
- To verify that all errors have been properly corrected as per Good Documentation Practice (GDP) and ALCOA.
- Annual Product review (APR) and Continued Process verification preparation (CPV) To Summarize and compile the information on the APR or CPV from the information received from all departments, provide all reference sources to the Quality Assurance Manager to review and evaluate the APR.
- After approval of APR, compile all appendixes to supply a complete file to the customers.
- To verify control and consistency of the manufacturing process.
- To identify and highlight any trends in critical process parameters (CPPs) and critical quality attributes (CQAs) to determine any potential impact on product quality and identify any opportunity for product and process improvement if necessary.
- To perform process capability analysis (Cp & Cpk) of Critical process parameters and Critical quality attributes of different products.
- Other responsibilities
- To participate in investigation in case of the deviation or non-conformance related to quality systems and procedures initiate corrective actions and provide feedback.
- To prepare risk assessment based on the description of an event.
- Preparation and review of standard operating procedures (SOP’s).
- To provide cGMP and GDP Trainings to new employees on join up with organization.
- To provide refreshment trainings of different SOPs to all concerned employees as a part of the corrective action to ensure that relative incident or deviation will not be happen again in near future.
Pharmacy Assistant
Medisystem Pharmacy
Winnipeg, Canada
10.2019 - 11.2019
- Corrected Patient medication pouches by using Pac vision software.
- Compounding, Filling Inhalers, creams, bubble packs etc.
- Sort, scan and process all items to be shipped Print shipping labels and packing slips.
- Delivered completed product based on schedules.
- Verified that all regulatory legislation is followed to ensure product quality during transportation.
- Assist in filling a variety of prescriptions efficiently to maintain workflow.
- Synchronization and collaboration with other departments.
- Ensure organization of workstation and inventory shelves.
- Some involvement in prescription information management.
IPQA Associate
Baxter Pharmaceuticals India Pvt Ltd
Ahmedabad, India
10.2017 - 08.2019
- To ensure compliance of current good manufacturing Practice in the small volume parenteral Plant (Terminal sterilization).
- To give line-clearance at different stages of manufacturing and packaging process.
- To perform IPQA (In-process Quality Assurance) activities at dispensing, filtration, filling, sealing, and packing stages etc.
- To participate in contract giver/regulatory agency’s audit compliance.
- To check and visit areas for IPQA starting from material receipt to pre-dispatch inspections, and reporting the abnormalities observed gets rectified and deviations are reported through a note to the concerned heads.
- To verify complete dispensing procedure with production operator during manufacturing of any product batch and the documentation of the same.
- To Verify sterilization recipe before start of Terminal sterilization and review the sterilization documentation online.
- To withdraw sterilization samples after terminal sterilization.
QA Officer
Alidac Pharmaceuticals Ltd
Ahmedabad, India
07.2015 - 10.2017
- To ensure compliance of current good manufacturing Practice in the small volume parenteral Plant (Aseptic filling - oncology manufacturing plant).
- To review executed batch manufacturing and batch packaging records.
- To prepare Annual product quality review.
- Successfully completed Continued Process Verification Project.
- To prepare and review QA SOPs.
- To give line-clearance at different stages of manufacturing and packaging process.
- To perform IPQA (In-process Quality Assurance) activities at dispensing, compounding, filtration, filling, sealing, and packing stages etc.
- To perform sampling activities as per BMR, BPR and Protocols.
- To participate in contract giver/regulatory agency’s audit compliance.
- To check and visit areas for IPQA starting from material receipt to pre-dispatch inspections, and reporting the abnormalities observed gets rectified and deviations are reported through a note to the concerned heads.
- To verify complete dispensing procedure with production operator during manufacturing of any product batch and the documentation of the same.
- Withdrawal of Retain samples during packaging process as per in-house procedure.
IPQA Officer
Claris Otsuka Pvt Ltd
Ahmedabad, India
02.2014 - 06.2015
- To ensure compliance of current good manufacturing Practice in the Large volume parenteral plant (Terminal Sterilization Plant) To give line-clearance at different stages of manufacturing and packaging process.
- To perform IPQA (In-process Quality Assurance) activities at dispensing, filtration, filling, sealing, and packing stages etc.
- To participate in contract giver/regulatory agency’s audit compliance.
- To check and visit areas for IPQA starting from material receipt to pre-dispatch inspections, and reporting the abnormalities observed gets rectified and deviations are reported through a note to the concerned heads.
- To verify complete dispensing procedure with production operator during manufacturing of any product batch and the documentation of the same.
- To Verify sterilization recipe before start of Terminal sterilization and review the sterilization documentation online.
- To withdraw bioburden samples after filling and sterilization samples after terminal sterilization.
QA Chemist
Halewood Laboratories
Ahmedabad, India
11.2012 - 02.2014
- To ensure compliance of current good manufacturing Practice in the Tablet manufacturing plant To give line-clearance at different stages of manufacturing and packaging process.
- To perform IPQA (In-process Quality Assurance) activities at dispensing, compression, coating and packing stages etc.
- To check physical parameters of tablets like average weight, hardness, thickness and disintegration test.
- To participate in contract giver/regulatory agency’s audit compliance.
- To check and visit areas for IPQA starting from material receipt to pre-dispatch inspections, and reporting the abnormalities observed gets rectified and deviations are reported through a note to the concerned heads.
Education
Master of Pharmacy -
APMC college of pharmaceutical education and research
06.2012
Bachelor of Pharmacy -
K.B institute of pharmaceutical education and research
04.2010
Skills
- Self esteem
- Multitasker
- Excellent interpersonal and communication skills
- Proficient in Microsoft Office word, Excel, and PowerPoint
- Strong attention to detail with accuracy
- Good working knowledge of Quality software SOLABS QM, LSM ,M2M
- Excellent knowledge of cGMP, GDP, Data Integrity and ALCOA principles
- Deadline-oriented
Volunteer Experience
Administrative Assistant, 10/2019, Altered Minds Inc., Winnipeg, Canada
Accomplishments
- Successfully completed Continued Process Verification Project in Alidac Pharmaceutical Limited as well as in Genvion Corporation.
- Currently working as a Project Lead in Online Packaging Job Order Review Optimization Project in IVC Vita Health.
Reference
Rosalia Alvarez
Quality Assurance Manager
Jamieson Wellness Inc.
Windsor,Ontario, Canada
Nikunj Patel
Lead Supervisor, Quality Operations
IVC Vita Health
Winnipeg, Canada
Timeline
QA Reviewer II
IVC VITA HEALTH
04.2022 - Current
QA Associate
Genvion Corporation
12.2019 - 04.2022
Pharmacy Assistant
Medisystem Pharmacy
10.2019 - 11.2019
IPQA Associate
Baxter Pharmaceuticals India Pvt Ltd
10.2017 - 08.2019
QA Officer
Alidac Pharmaceuticals Ltd
07.2015 - 10.2017
IPQA Officer
Claris Otsuka Pvt Ltd
02.2014 - 06.2015
QA Chemist
Halewood Laboratories
11.2012 - 02.2014
Master of Pharmacy -
APMC college of pharmaceutical education and research
Bachelor of Pharmacy -
K.B institute of pharmaceutical education and research
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