Mentor Technical Group provides technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG ensures compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.
Requirements
- Review and audit validation, qualification, and verification activities
- Participate in defining validation/qualification strategies for product transfers and site product changes
- Review and approve Operational Qualification (OQ), Performance/Process Qualification (PQ), and Verification activities
- Coordinate Change Requests (CRs) for qualified production records, equipment, systems, and facilities
- Assess the regulatory impact of proposed changes and ensure completeness of documentation prior to approval
- Support PCF sponsors in preparing change requests by providing regulatory documentation
- Create and revise export profiles for assigned products
- Support activities related to new R&D products, including change controls, development, and validation documentation
- Contribute to the APR process
- Review documentation and change controls related to shipping labels and artwork
