Senior Specialist, QA (CGT)

The QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility.

• Identify cGxP/cGDP non-compliance, provide guidance, and support basic compliance queries across departments.
• Review batch records and logbooks, raise deviations, compile lot genealogy, and prepare lot disposition packages to ensure timely product release.
• Oversee product status, shipping documentation, material release, joint inspections, and quality tag-out processes.
• Participate in deviation investigations using RCA tools and ensure timely CAPA implementation and closure.
• Provide QA oversight for document changes, changeovers, and Quality Change Requests.
• Conduct shopfloor walkdowns, elevate process events per SOPs, and support regulatory and customer audits.
• Lead or support QA projects and build stro...

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