Manager - QA Engineering Documentation (API)

Job description

Role & responsibilities Key Responsibilities: • Review and approve engineering-related documents such as qualification protocols, reports, SOPs, and logbooks. • Ensure compliance of equipment qualification (IQ/OQ/PQ) and validation documentation. • Handle change controls, deviations, CAPA, and investigations related to engineering systems. • Review preventive maintenance records and calibration documents. • Ensure compliance with cGMP, data integrity, and regulatory requirements. • Support regulatory audits (USFDA, WHO, MHRA, EDQM) with engineering documentation readiness. • Coordinate with Engineering, QA, and Production teams for documentation compliance. • Ensure effective documentation control and archival as per quality systems.