Job description
Role & responsibilities
- Strong knowledge of API manufacturing processes.
- Experience in batch release management, ensuring compliance with regulatory and internal requirements.
- Review of executed batch records, including audit trail review for data integrity compliance.
- Preparation and review of Annual Product Reviews (APR) in line with regulatory expectations.
- Preparation and review of Process Validation protocols and reports.
- Review of technology transfer documents and data for completeness and compliance.
- Initiation, review, and management of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA.
- Oversight of dispatch activities and line clearance to ensure compliance with GMP requirements.
- Experience in cleaning validation, including protocol and report review.
- Conducting internal audits and ensuring timely closure of audit observations
Preferred candidate profile
- Strong experience in API manufacturing within a GMP-regulated environment
- Hands-on experience in batch release, BMR/BPR review, and QMS management (Deviation, OOS, CAPA, Change Control)
- Proven exposure to regulatory and customer audits (WHO/GMP, preferred) (USFDA/EMA)
- Experience in validation, APR/PQR, stability studies, and technology transfer activities
- Strong understanding of data integrity and risk assessment practices
Education
UG: B.Pharma in Pharmaceutical, Pharmaceutical Chemistry
PG: M.Pharma in Pharmacy, MS/M.Sc(Science) in Chemistry
Job Type: Full-time
Pay: ₹45,000.00 - ₹50,000.00 per month
Work Location: In person
