QC Assistant Manager
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Posted on:
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Job Summary
Laboratory Management: Oversee the daily operations of the QC Raw Material section including work allocation shift planning and ensuring the timely testing and release of APIs excipients and packaging materials to support production schedules.
Data Review & Approval: Perform secondary review of analytical test data chromatograms and audit trails generated from sophisticated instruments (HPLC GC FTIR UV-Vis Karl Fischer Auto-Titrators) for accuracy and compliance.
QMS & Investigations: Lead laboratory investigations for Out of Specification (OOS) Out of Trend (OOT) and routine deviations. Implement effective Corrective and Preventive Actions (CAPA) and evaluate change controls related to the RM section.
Compliance & Data Integrity: Ensure strict adherence to ALCOA principles and Data Integrity guidelines across all laboratory operations. Monitor electronic data systems (e.g. Empower 3) and ensure contemporary documentation practices.
Required Experience:
Manager
