Teva Quality Sr Specialist 

India, Karnataka, Bengaluru 

959341482

• 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

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

• 1 to 3 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 PQR compilation would be preferred

Group Leader, Quality Assurance

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