Adarsh Marmat
QA Manager at J&J, Ex. GSK
- Role
- Quality Assurance Manager at Johnson & Johnson
- Location
- Aurangabad, MH, IN
- LinkedIn followers
- 500 followers
About Adarsh Marmat
I, Adarsh Marmat (Masters in Pharmaceutical Sciences - Punjab University, Chandigarh…
Experience
Quality Assurance Manager
Jan 2018 — Present
Providing Quality and Compliance Leadership in Quality and ensuring compliance to Regulatory norms • Leading Quality Team to deliver Quality Objective of Organization.• Review and Approve Quality Documents i.e. Change Controls, Non-conformance / Deviation, Investigation / Root Cause Analysis, Effectiveness monitoring, Market Complaints, Artworks and Print Proof, APQR / PQR, Stability Study Protocols, Reports and Schedule, Validation Protocols and Reports• Working as Non-Conformance and CAPA Site Lead• Conduct Management Review Meetings• Coordinate transaction to revised Regulations and Standards – ISO 9001 and ISO 13485• Lead Auditor for ISO 13485:2016 and Participate in Internal and External Regulatory Inspections • Drive Field Action / Product Recall
Education
Panjab University
M. Pharmacy, Master of Pharmacy
2002 — 2004
Shri JJT University
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
2012 — 2015
B. N. College of Pharmacy
B. Pharamacy, Pharmacy
1997 — 2001
Adarsh Vidhya Mindir
12th, Science Bio
1993 — 1995
Skills
- Corrective and Preventive Action (Capa)
- Technology Transfer
- Validation
- Sop
- Fda
- Cleaning Validation
- Capa
- Quality System
- V&V
- Regulatory Affairs
- Gmp
- Glp
- U.s. Title 21 Cfr Part 11 Regulation
- 21 Cfr Part 11
- Quality Auditing
- Regulatory Requirements
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