Production Documentation - Assistant Manager

Assistant Manager API Production Documentation

Job Summary

We are looking for an experienced professional 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]