Company Name: Enzene Biosciences Ltd Designation: Senior Executive Department: IPQA PQR & CPV SME for DS/DP 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

- Solid knowledge of PQR/APQR requirements.
- Statistical data analysis and trend evaluation.
- Excellent computer skills, including:
- MS Excel (advanced)
- PowerPoint
- Graphical data presentation.
- Strong 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