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Teva Quality Sr Specialist 
India, Karnataka, Bengaluru 
858779577

10.09.2024
The opportunity
  • 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

A. 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

B. 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

C. 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

D. Performance Management

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

E. Training

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

F. Miscellaneous Support

  • Any other tasks assigned by the management for smooth functioning of the team
Your experience and qualifications
  • 3 to 5 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 or MSc in Chemistry
  • 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.
Reports To

Group Leader, Quality Assurance

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