Teva Quality Specialist III - APQR 

India, Karnataka, Bengaluru 

953381391

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

1. 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

1. 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

1. 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

1. Performance Management

• Participate in continuous process improvement projects to improve efficiency of the unit

1. Training

• Prepare the Training Materials for GMP training and on the job training.
• Imparts training on procedures as needed.

1. Miscellaneous Support

• Any other tasks assigned by the management for smooth functioning of the team

• 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.