Posted: 1 week ago
Posted: 1 week ago
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Job Description
- 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.
Skills
AuditAuditsBmrBmr/bprBprCapaCgmpChange ControlCleaning ValidationAudit ComplianceGmpGmp ComplianceInternal AuditsInvestigationInvestigation ManagementOosOotProcess ValidationQaQcQmsSopsIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
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