Senior Executive
Enzene Biosciences
- Location
- Pune Division, Maharashtra, India
- Job type
- Full-time
Required skills
- cross-functional
- data presentation
About the role
Enzene Biosciences
Website:
enzene.com
Job details:
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.
- Strong technical writing and report preparation skills.
- Effective communication and cross-functional coordination skills.
Education:
MSc, M Pharma, M Tech in related field
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