Description
Project Position Purpose- This project position provides validation and compliance support (V&C) to the Global Operations (GO) Validation and Compliance team for the purpose of executing specific aspects of the GO Vendor Management program.
- This project role will support the collection/review and assessment of vendor self-inspection questionnaires.
- Included will be maintaining project SharePoint list and reporting on project status and completion percentages.
- Reports to the Manager Validation and Compliance
- Send out vendor questionnaires associated with internal GO vendor management SOP
- Receive returned questionnaires from vendors, and complete an assessment of responses and request further supporting documentation as necessary
- Maintain vendor list, and report compliance with process
- Provide Direct Follow up with vendors to expedite responses and answer vendor questions
- Update vendor information in vendor management SharePoint tool
- Maintain running project schedule to meet established project timelines provided by company
Training and Education/Prior Experience Preferred
- A BS or MS degree in one or more of the following; scientific related discipline such as Chemistry, Physics, Engineering, Biochemistry, Biology, Quality Control, or facilities.
- A minimum of 5 years experience in compliance, metrology, pharma manufacturing or other practical QA related field
- Experience in Pharmaceutical R&D industry operations and cGMP/cGLP and cGCP compliance is preferred
- MS Office suite experience, specifically MS Excel, MS Project
- Good communication and organization skills a must
- Project management skills
- The ability to drive vendors to respond
- Decision making
- An understanding of what the vendors service is in support of