Manager - Quality Assurance - QMS (API)

Job description

**Designation:** Manager QA QMS **Qualification:** B.Sc / M.Sc / B.Pharm / M.Pharm **Experience:** 815 Years **Key Responsibilities:** - Manage and oversee **Quality Management System (QMS)** activities in API manufacturing. - Handle **deviations, CAPA, change controls, incidents, and investigations** . - Review and approve **SOPs, protocols, reports, and quality documentation** . - Ensure compliance with **cGMP, data integrity, and regulatory requirements** . - Conduct and coordinate **internal audits** and support external regulatory audits. - Monitor **market complaints, product quality reviews (PQR), and risk assessments** . - Ensure effective implementation of **quality systems and continuous improvement initiatives** . - Coordinate with cross-functional teams for compliance and closure of quality observations. **Required Skills:** Strong expertise in **QMS activities in API manufacturing** Good knowledge of **deviations, CAPA, change controls, and investigations** Exposure to **regulatory audits** such as **USFDA, WHO, MHRA, and EDQM** Strong documentation, compliance, and team management skills Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.