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.