Lab QA - Sr. Executive
Lab QA - Sr. Executive
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Job Description
Document Review: Review analytical test reports raw data chromatograms stability reports and logbooks for accuracy and compliance.
Deviation & OOS Handling: Support investigation and closure of OOS OOT deviations and lab incidents ensuring implementation of CAPA.
Audit & Compliance: Ensure the lab is audit-ready by maintaining compliant documentation and systems and participate in regulatory inspections (USFDA MHRA WHO EU-GMP).
SOP & Change Control: Review and update SOPs method transfer protocols change controls and technical documentation.
Data Integrity Monitoring: Conduct periodic reviews and audits of QC data to ensure compliance with ALCOA principles.
Training & Support: Support in training QC personnel on SOPs data integrity documentation practices and regulatory guidelines.
Quality Systems Oversight: Monitor LIMS entries laboratory logbooks and analytical workflows to ensure end-to-end traceability and compliance.
Required Experience:
Senior IC
Employment Type
Full-Time
