- Title: Global Product Quality Audit Coordinator
- Code: RCI-0346
- Location: Princeton, New Jersey 08540 (Temporary Remote)
- Posted Date: 09/17/2021
- Duration: 12 Months
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- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
- Support Global Product Quality – Supplier Quality Team, including Inspections, OPDC Audit Program and Global Audit Program, international conference calls
- Ensure all required audits (internal and external) are planned and scheduled
- Monitor adherence to Audit schedule which includes following up with auditors on scheduling and completion of audits
- Maintain the Internal and External Audit Plans, TrackWise Vendor Management system, ensuring the Approved Supplier List is up to date.
- Reconciliation of all Internal/External Audit Documentation
- Administer GMP Supplier Quality mailbox, Team SharePoint site, and GMP Team records (document storage, archiving, retrieval).
- Support TrackWise Enhancements for Vendor Management and Audit workflows and assist in UAT testing.
- Support Global Quality Data Studio (GQDS) for Vendor Management and management of OPDC internal and external audits
- Compile and report key performance indicators, metrics and compliance status of Internal Audits and External audits
- Monitor qualification status of Qualified Auditors and coordinate with them to maintain their status current with Qualification.
- Author Standard Operating Procedures, work instructions, forms, templates and other documents
- Support creation of training and job aids
- Recognize potential GMP issues and rectifies/escalates, including creation of internal Planned/Unplanned Deviations as needed
- Independent worker requiring minimal supervision
- Works collaboratively within Global Product Quality and other functions across Affiliates and Subsidiaries to ensure compliance to internal standards and regulatory requirements
- Collaborate with cross functional teams and provide guidance in completing ad hoc audit requests.
- Assist the department in conducting risk assessments per the established audit tools and submit to Manager for review and approval.
- BA/BS Degree
- 6 + Years of experience working within Quality
- Ability to commute to Princeton, NJ post Covid minimum 5 days per week