Assistant Manager API Production Documentation

Job Summary

We are looking for an experienced qualified to manage API Production documentation and QMS activities. The role will be responsible for BMR/BPR preparation and review, GMP/GDP compliance, deviations, CAPA, Change Control, OOS/OOT investigations, SOPs, and material reconciliation.

Key Responsibilities

- Prepare, review, and issue BMR/BPR for API manufacturing batches.
- Ensure compliance with GMP, GDP, ALCOA+ and Data Integrity requirements.
- Handle Production-related Deviation, CAPA, Change Control, OOS/OOT documentation and investigations.
- Support RCA, impact assessment, and timely closure of QMS activities.
- Prepare/revise SOPs, formats, logbooks, work instructions, and batch documents.
- Review material consumption, reconciliation, batch yield, and production records.




- Maintain QMS trackers and support internal/customer/regulatory audits.
- Coordinate with Production, QA, QC, Warehouse, Engineering, Validation, and R&D;/Technology Transfer teams.

Qualification & Experience Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc. / B.E. / B.Tech. or equivalent.

Experience: 4–8 years in API/Pharmaceutical Production, preferably with hands-on experience in Production Documentation and QMS activities.

Key Skills

API Production | BMR | BPR | GMP | GDP | ALCOA+ | Data Integrity | Production Documentation | Deviation | CAPA | Change Control | OOS | OOT | RCA | SOP | Batch Documentation | Material Reconciliation | QMS | Audit Compliance

Interested candidate can share there cv's at [email protected]

📌 Production Documentation - Assistant Manager (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar