The opportunity
This incumbent
Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
Review of Instrument/Equipment Qualification records.
Review of BMR.
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/QC/Technical support personnel located globally for data collection and arranging responses.
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
How you’ll spend your day
Review of CMC Documentation –
The owner of the function
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
Data requesting and Compilation of PQR’s
The owner of the function
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
Quality Management Systems
The owner of the function
Initiate the process of change controls and deviations
Preparation of local SOP’s and its related documents.
Participate in self-inspection process
Performance Management
Participate in continuous process improvement projects to improve efficiency of the unit
