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.
