Job
Description
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, RD 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 Your experience and qualifications 2 to 8 years of experience in QA / QC function in the pharmaceutical industry Master s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences Basic knowledge on worldwide cGxP regulations Good English language skills, other language skills could be helpful Good communication skills Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage Basic understanding of manufacturing, QC and Contract manufacturing processes Engagement to drive improvements and ability to manage complexity Hands-on experience on Analytical Method development, Method Validation for API and FP of different analytical methods (e.g. Assay, impurities, dissolution etc.) Stability Studies. Hands-on experience on Review of Instrument/Equipment qualification records. Basic knowledge / hands on experience of review of BMR. Basic knowledge / hands on experience on Product Quality Reviews
