Manager - Quality Assurance - QMS (API)

Designation: Manager ? QA QMS
Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm
Experience: 8?15 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

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