Posted:2 months ago| Platform:
Work from Office
Full Time
Responsibilities: Manage preparation, review, and timely revision of SOPs, GTPs, and guidelines. Oversee DMS applications and ELN systems. Review and approve analytical protocols, reports (e.g., Method Validation, Verification, Regulatory Queries, Equivalency, PDR, MFC, AMT), and instrument qualifications. Conduct internal audits, lab monitoring, and ensure compliance with GDP and GLP standards. Provide training, review QMS documents (Incidents, Deviations, Change Control), verify electronic data, perform audit trail reviews, and assess Computer System Validation reports
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