- Peptide Upstream Downstream Manufacturing: 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. 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.

- Review and approve IQ, OQ, and PQ protocols and reports for equipment, utilities,



facilities, and computerized systems.

- Support Process Validation, Cleaning Validation, and Technology Transfer activities.

- Ensure compliance with cGMP, Data Integrity, USFDA, EU GMP, and ICH guidelines.

- Drive inspection readiness, quality culture, and continuous improvement initiatives.

- Coordinate with Manufacturing, QC, Engineering, Warehouse, and Regulatory teams.

- Key Skills: GMP Compliance, QMS Management, Audit Handling, IQ/OQ/PQ, Validation, Investigation Management, Leadership, and Regulatory Compliance.

📌 Deputy Manager, Manufacturing Process Operations (Dahej)
🏢 Amneal India
📍 Dahej