Deputy Manager, Manufacturing Process Operations
GujaratFull-time8–12 yrsPosted 6 days ago
Leadership mechanical and production role at Hcfa in Gujarat. Needs 8–12 years and an M.Sc, B.Pharm or M.Pharm.
About the role
Lead SPPS operations covering resin charging/swelling, Fmoc deprotection, amino acid coupling, washing, cleavage and filtration. Ensure execution as per approved BMR/BPR, SOPs, process parameters, quality requirements and production schedules; monitor yields, solvent/material consumption and equipment utilization.
What you'll do
- Ensure execution as per approved BMR/BPR, SOPs, process parameters, quality requirements and production schedules; monitor yields
- Manage QMS activities including Deviation, CAPA, Change Control, OOS, OOT, Risk Assessment, and Audit Compliance
- Review and approve SOPs, protocols, reports, and quality documents
- Lead customer, regulatory, and internal audits ensuring GMP compliance
- Provide QA oversight for FAT, SAT, Commissioning, and Validation activities
What you need
- ISO 9001
- GMP
- Compliance
- Audit
- SOP writing
- Internal audit
Good to have
- Chemistry