In an inter-departmental team environment, works to facilitate/incorporate effective quality practices for new and existing clients. Acts as the Primary Quality Assurance Representative for designated clients. Review and approval of GMP Certificates of Analysis (CoA’s), deviations, and CAPAs. Reviews, as necessary manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable. Monitor processes for adherence to
established procedures/regulatory compliance.
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