Assistant Manager

Job Summary

We are looking for an experienced Assistant Manager to support and manage day-to-day API manufacturing operations, ensuring production targets, product quality, safety, and GMP compliance. The role will involve production planning, team handling, process monitoring, documentation, and coordination with QA, QC, Engineering, and other departments. API manufacturing responsibilities should align with GMP expectations under ICH Q7.

Key Responsibilities

Plan, execute, and monitor API production activities as per approved manufacturing procedures and production schedules.

Ensure achievement of production targets, yield, productivity, and batch timelines.

Supervise manufacturing processes including reaction, filtration, centrifugation, drying, milling, blending, and solvent recovery.

Review and ensure accurate completion of BMR/BPR, logbooks, SOPs, and other GMP documentation.

Ensure compliance with GMP, SOPs, EHS, and safety requirements.

Monitor process parameters and identify deviations, abnormalities, and process-related issues.

Coordinate with QA/QC, Engineering, Warehouse, EHS, and R&D for smooth production operations.

Support investigation of deviations, OOS/OOT, CAPA, change controls, and process improvements.

Manage manpower, shift activities, training, and performance of production personnel.

Ensure proper cleaning, equipment maintenance, calibration, and line clearance.

Drive yield improvement, solvent recovery, waste reduction, and productivity improvement initiatives.

Support internal, customer, and regulatory audits and ensure timely closure of observations.

Required Skills

Strong knowledge of API manufacturing processes and GMP.

Knowledge of ICH Q7 / cGMP requirements.

Experience in batch manufacturing and production planning.

Strong manpower handling and team management skills.

Good knowledge of BMR/BPR, SOP, deviation, CAPA, change control, and investigation.

Problem-solving and troubleshooting skills.

Good communication and cross-functional coordination abilities.

Working knowledge of MS Excel, ERP/SAP, and production reporting