Provide Quality Operations (QA) oversight for API manufacturing and production support activities to ensure compliance with GMP requirements.
Review incoming material inspection packages, batch records, manufacturing logs, and quality documentation before product release.
Support batch disposition and release of incoming materials, intermediates, and finished products.
Perform routine shopfloor quality walkthroughs across manufacturing, engineering, warehouse, and QC laboratories to ensure compliance with GMP and company procedures.
Participate in deviation investigations, root cause analysis, and CAPA implementation for quality-related issues.
Support change control activities, ensuring changes are implemented in accordance with quality systems and regulatory requirements.
Monitor and maintain quality logs, including QA Holds and QA Tag Outs.
Support new product introduction (NPI), operational excellence in...
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