Job Description
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Pharmaceutical Quality Assurance (QA) role ensures drug products meet safety, efficacy, and regulatory standards by overseeing documentation, processes, audits, and batch release, focusing on building quality into manufacturing (cGMP) through activities like SOP review, deviation investigation, validation, and supplier qualification, preventing errors rather than just detecting them. Key duties include reviewing batch records (BMRs), managing change controls, investigating out-of-specification (OOS) results, conducting audits, and releasing finished products for distribution, all while maintaining compliance with guidelines like GMP, GCP, GDP.
Core Responsibilities
Document Control: Reviewing and approving Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and other quality documents.
Batch Record Review: Ensuring manufacturing and packing documents are complete, accurate, and compliant before product...
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