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53 Watson Pharmaceuticals Jobs
Quality Specialist III
Watson Pharmaceuticals
posted 10hr ago
Job Role Insights
Fixed timing
Key skills for the job
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.
Employment Type: Full Time, Permanent
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Strict timing
Monday to Friday
No travel
Day Shift
Watson Pharmaceuticals Benefits
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