Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations. Cross-functional quality responsibilities will include investigation support, review of change controls, NC/CAPA/Change Control management, review of documentation, day-to-day quality support.
Responsibilities include:
• Review and Approval of Investigations, CAPAs, and Change Controls
• Audit and Inspection Support for quality processes
• Review and approval of documentation
• Support generation, review and approval of documentation
• Metrics reporting
• Own and drive to closure Investigations, CAPAs, and Change Controls
• Support training activities
• Support program alignment and integration into the Client Quality Systems