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

Ipca; Ratlam; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Ipca in India seeks an experienced API batch manufacturing professional to drive batch execution with focus on yield and cycle-time control. The role requires hands-on production, cGMP compliance, and accurate batch documentation.

You will manage technology transfer from development to commercialization, investigations, CAPA, and trend analysis, while supporting audits and continuous improvement through DOE and Lean methods. Strong SAP/ERP, MES, and Excel skills are essential.

Responsibilities

• API batch manufacturing with hands-on experience on commercial batches, yield and cycle-time control
• cGMP compliance and accurate BMR/BPR preparation and batch documentation
• Technology transfer and scale-up from R&D/clinical to commercial; pilot trials
• Deviation investigation, RCA, CAPA implementation and trend analysis
• Regulatory audit readiness support (USFDA, EU, MHRA, CDSCO)
• Process optimization using DOE and statistical tools; Lean/Kaizen mindset
• Production planning, OEE tracking, shift management and KPI ownership
• QA/QC coordination for release, stability and QC sampling

Tools

SAP/ERP

MES

MS Excel

Job description

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