About this role
- 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.
Qualification: M.Pharm / B.Pharm / M.Sc. Chemical Engineering (Chemistry/Biotechnology)
Experience: 8-12 years in QA/QMS of API or Peptide manufacturing.