A. Review of CMC Documentation:
- Review of Method Development / Validation protocols & reports.
- Review of Stability Study protocol, reports & grids.
- Review of Instrument / Equipment Qualification records.
- Review of Batch Manufacturing Records.
- Liaising with contracting Teva units and QA/QC personnels located globally for arranging required documents and query responses.
- Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.
- Contemporaneous updation of SharePoint data base
B. Data requesting and Compilation of PQR’s:
- Compilation of high quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products manufactured at various manufacturing sites and retrieve data from the Quality and regulatory databases and systems
- Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs.
- Follow up with the CMO‘s for the receipt of data within time.
- Check quotation received from CMO and initiate PR/PO for QP’s approval.
- Once the data is received responsible for filling the PQR receipt checklist and scheduling the PQR in SharePoint.
- Escalation of PQR issues to Supervisor, Group Leader, Manager PQR Centre.
- Contemporaneous updation of SharePoint data base
C. Quality Management Systems:
- Initiate the process of change controls and deviations
- Preparation of local SOP’s and its related documents.
- Participate in self-inspection process
D. Performance Management
- Participate in continuous process improvement projects to improve efficiency of the unit
E. Training
- Prepare the Training Materials for GMP training and on the job training.
- Imparts training on procedures as needed.
F. Miscellaneous Support
- Any other tasks assigned by the management for smooth functioning of the team