Manages the supplier qualification program to include external audit program, maintenance of Approved Supplier List, supplier metrics and relationships. Work within the realms of GMP systems to facilitate batch release, change control, and deviation, particularly as they relate to vendor management. Support on-site clinical manufacturing activities to support all incoming component and material release ensuring complaint, robust and consistent manufacturing, testing and clinical development processes are established and maintained.
Internal Audit Program:
Coordinate sample transfers to testing laboratories for incoming reagents, in-process materials, finished drug product and stability samples.
Identify process improvement initiatives and quality measurement tools to monitor and improve quality and technical operations. Implement appropriate process improvement initiatives throughout the development programs and supply chain including the evaluation of the success of the initiatives.
Evaluate impending regulations, guidelines and industry standards and their impact on the company and contract operations, Provide expertise and training to other departments in support of these standards and guidelines.
Responsible for the technical writing and approval SOP’s, protocols, reports, specifications and other GMP documentation as needed to ensure robust and sustainable quality systems are in place.
SPECIALIZED KNOWLEDGE, LICENSES, CERTIFICATIONS: