Quality Specialist III

2 - 8 years

5 - 11 Lacs

Posted:4 months ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

  • 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.

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Watson Pharama

Pharmaceuticals

Pharma City

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