Experienced Quality Assurance professional with 10+ years in pharmaceutical manufacturing. Specializes in equipment qualification, facility validation, cleaning validation, and process validation. Proficient in shop floor management, risk assessments, audit preparedness, and compliance documentation maintenance.
Hi, I’m
Prathamesh Mandrekar
QA, Risk Consultant
Bardez
Summary
Overview
11
years of professional experience
6
years of post-secondary education
4
Languages
Work History
Ernst & Young LLP
Risk Consultant – Life Sciences
09.2024 - Current
Job overview
- Led a team of consultants in planning and executing validation activities for computerized systems and equipment, ensuring alignment with project timelines and regulatory expectations.
- Conducted and reviewed gap assessments to identify deviations from regulatory requirements and industry best practices.
- Formulated and implemented remediation strategies to close gaps, and maintain audit readiness.
- Directed the preparation and review of CSV and qualification documentation, including URS, FRS, DQ, IQ, OQ, PQ, and validation reports, aligned with GAMP 5 and 21 CFR Part 11.
- Strengthened stakeholder relationships by providing transparent and timely updates on risk management efforts, fostering a culture of trust and collaboration.
Sanofi India Limited
Asst. Manager, QA
08.2022 - 09.2024
Job overview
- Functioned as a Qualification SME, leading equipment, utility, and facility qualification efforts in line with regulatory and lifecycle expectations.
- Managed a QA team overseeing shop floor compliance, documentation, and qualification activities across production and utility systems.
- Prepared risk assessments for process validation, reviewed protocols and reports for compliance and completeness, and monitored the execution of validation batches to ensure adherence to approved protocols.
- Reviewed and evaluated change controls, conducted deviation investigations, and tracked CAPA implementation to ensure timely and effective resolution.
- Investigated market complaints in coordination with cross-functional teams, and contributed to root cause analysis and documentation.
- Served as a self-inspector and data integrity focal point, evaluating systems and processes to ensure compliance with ALCOA+ principles and corporate policies.
- Released batches through SAP, and led APQR compilation and process validation execution to support commercial manufacturing.
Unichem Laboratories Ltd
Executive, QA
11.2020 - 07.2022
Job overview
- Served as a Cleaning Validation SME, overseeing protocol development, swab sampling, MACO calculations, and campaign strategy execution.
- Acted as a CSV Subject Matter Expert, managing validation lifecycle documents and compliance for newly implemented systems during the greenfield setup.
- Contributed to equipment and utility qualification activities, including document preparation and execution across production and warehouse areas.
- Reviewed process validation protocols and reports for completeness, and regulatory alignment.
- Performed self-inspections and supported regulatory inspection readiness through internal audit follow-ups and CAPA tracking.
- Evaluated change controls for impact on validated systems, cleaning processes, and qualification status, ensuring documentation and compliance alignment.
- Investigated deviations related to cleaning failures and equipment qualification, performing root cause analysis, and ensuring effective CAPA implementation.
Glenmark Pharmaceuticals Ltd
Sr. Officer, QA
08.2014 - 10.2020
Job overview
- Performed IPQA and real-time monitoring of manufacturing processes on the production shopfloor, ensuring in-process compliance.
- Reviewed production records, logbooks, alarms, and audit trails to maintain GMP compliance and readiness.
- Participated in equipment and utility qualification, including protocol preparation, execution, and documentation aligned with regulatory expectations.
- Executed and reviewed cleaning validation protocols, including swab sampling, hold time studies, and campaign batch strategies.
Education
Goa College of Pharmacy, Goa UniversityPanjim
Bachelor of Pharmacy
01.2008 - 01.2012
University Overview
Goa College of Pharmacy, Goa University
Master of Pharmacy from Quality Assurance
01.2012 - 01.2014
University Overview
Skills
Effective team management
Audit Exposure
Audit Exposure
- USFDA
- MHRA
- Russian Agency
- WHO
- CDSCO
- SUKL
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Risk Consultant – Life Sciences
Ernst & Young LLP
09.2024 - Current
Asst. Manager, QA
Sanofi India Limited
08.2022 - 09.2024
Executive, QA
Unichem Laboratories Ltd
11.2020 - 07.2022
Sr. Officer, QA
Glenmark Pharmaceuticals Ltd
08.2014 - 10.2020
Goa College of Pharmacy, Goa University
Master of Pharmacy from Quality Assurance
01.2012 - 01.2014
Goa College of Pharmacy, Goa University
Bachelor of Pharmacy
01.2008 - 01.2012
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