Asst. Manager / Manager / Senior Manager / AGM - API Production

Role & responsibilities

- API batch manufacturing & execution handson experience with commercial batches, yield & cycletime control
- cGMP compliance, BMR/BPR preparation & batch documentation accuracy
- Technology transfer, scaleup from R&D/clinical to commercial, pilot trials
- Deviation investigation, RCA, CAPA implementation and trend analysis
- Regulatory audit readiness & support (USFDA, EU/MHRA, PMDA, CDSCO)
- Process optimization: DOE, statistical tools, continuous improvement (Lean/Kaizen)
- Production planning, OEE, manpower allocation, shift management and KPI ownership
- Quality interactions: coordination with QA/QC for release, stability and QC sampling
- Equipment/utility readiness: cleaning validation, changeover, preventive maintenance coordination
- Safety & HSE: hazardous chemical handling, SOPs, incident investigation, PPE and environmental compliance
- Systems & reporting: SAP/ERP, MES, MS Excel
- People & leadership: team development, training, stakeholder communication, conflict resolution
- Problem solving: analytical thinking, troubleshooting, project management for CAPEX/expansion