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:

- Strong 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