Lead and oversee GMP-compliant quality systems for a peptide API facility, including equipment qualification, CSV, vendor and contract lab qualification, training management, and document control, ensuring regulatory compliance, data integrity, and inspection readiness
Key Stakeholders: Internal
Operations, Engineering, QC, IT, and Supply Chain
Key Stakeholders: External
Vendors & External Service Providers
Reporting Structure
Head – Quality Assurance
Experience
10–15 years in QA within API / Peptide / Pharmaceutical manufacturing
Key Responsibility:
1. Equipment Qualification & CSV
• Provide overall leadership and strategic oversight for DQ, IQ, OQ, and PQ activities covering manufacturing, laboratory, utilities, and critical support equipment.
• Ensure qualification activities are planned and executed using a risk-based approach, in full compliance with GMP and data integrity requirements.
• Lead and govern Computer System Validation (CSV) for all GxP-critical computerized systems.
• Review, approve, and ensure adequacy of qualification/validation protocols, reports, deviations, and change controls.
• Actively support and drive the site digitization and automation initiatives as part of the Site Improvement Plan.
2. Vendor & External Party Qualification
• Establish and maintain systems for Vendor Qualification for raw materials.
• Lead Contract Laboratory Qualification, including technical assessment, documentation review, and audit oversight.
• Qualify and monitor external service providers (calibration, validation, maintenance, testing, and consulting agencies).
• Support supplier audits and regulatory inspections related to vendor management.
3. Training Management System
• Own and manage the training lifecycle for GMP, SOPs, equipment, systems, and job-specific competencies.
• Ensure training matrices are established, maintained, and periodically reviewed.
• Support audit-ready documentation for internal, customer, and regulatory inspections.
4. Documentation Issuance & Control
• Lead and oversee document control systems including SOPs, protocols, formats, manuals, and quality records.
• Ensure controlled issuance, revision, archival, and retrieval of GMP documents.
• Review and approve quality documents in alignment with site quality policies.
• Ensure compliance with ALCOA+ and data integrity principles.
5. Quality Systems & Compliance
• Support deviation management, CAPA, change control, OOS/OOT, and risk assessments related to qualification and validation activities.
• Participate in internal audits, vendor audits, and regulatory inspections.
• Provide quality guidance to cross-functional teams and ensure timely closure of audit observations.
