Responsibilities:
Independently prepare and maintain Annual Product Quality Reviews (APQR/PQR) for commercial products.
Develop and maintain a comprehensive PQR roadmap, tracker, and annual schedule.
Collect, compile, review, and analyse data from Manufacturing, QC, QA, Engineering, Warehouse, and RA functions.
Ensure timely completion and approval of PQRs as per regulatory commitments.
Data Trending & Analysis.
Recommend CAPAs and continuous improvement opportunities based on PQR outcomes.
Support Continued Process Verification (CPV) and Process Validation activities.
Support regulatory inspections and customer audits.
Present PQR data and quality trends during audits.
Skills:
Robust knowledge of PQR/APQR requirements.
Statistical data analysis and trend evaluation.
Excellent computer skills, including:
MS Excel (advanced)
PowerPoint
Graphical data presentation.
Robust technical writing and report preparation skills.
Effective communication and cross-functional coordination skills.
Education:
MSc, M Pharma, M Tech in related field
📌 Senior Executive Pune
🏢 Enzene Biosciences
📍 Pune
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