Purpose & Scope:

Review and approve batch records, deviation investigations, and reports. Provide inter- and

intradepartmental support in the preparation and review of documentation related to and including manufacturing processes, equipment, and computer systems that affect GMP-related activities.

Administers the QA deviation and CAPA system, internal audit system, supplier audit system, and

all other necessary quality systems. Provides GMP guidance to other departments and project

teams.

Essential Job Responsibilities:

• Assist in the investigation, reporting, and resolution of major deviations
• Review and approval of validation protocols and reports
• Review and approval of all GMP document revisions including SOP's, MPR's, specifications, test methods, etc.
• Administration of the deviation and CAPA system
• Administration of the internal audit and supplier audit ...