The opportunity
Ensures that the Product Quality Reviews / Annual Product Reviews for Teva products are completed in a timely and compliant manner as per Teva’s CORP Quality Management systems. PQR/APR compilation and approval must be well associated with the Teva Manufacturing Sites, Global Quality Units and Commercial affiliates to meet the targets and ensure compliance.
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 system
Liaising with third party contract manufacturers and QA personnel located globally for data collection required for compilation of APRs/ PQRs
Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
Receives guidance from Supervisor, Group Leader, Manager Global Quality Services, Associate Director Global Quality GBS, other Managers in Quality Strategy & Shared Services, EMSO Quality affiliates, Commercial Quality EU & IM, TGO sites x`
How you’ll spend your day
A. 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
B. 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
C. Performance Management
Participate in continuous process improvement projects to improve efficiency of the unit
D. Training
Prepare the Training Materials for GMP training and on the job training.
Imparts training on procedures as needed.
E. Miscellaneous Support
Any other tasks assigned by the management for smooth functioning of the team
