Quality Sr Specialist
Bangalore, India, 560064
Who we are
The opportunity
This incumbent
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Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
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Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
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Review of Instrument/Equipment Qualification records.
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Review of BMR.
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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.
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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
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Liaising with third party contract manufacturers and QA/QC/Technical support personnel located globally for data collection and arranging responses.
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Recommend actions and professionally communicate to sites/ Quality units for continuous improvement in quality of products
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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
How you’ll spend your day
- Review of CMC Documentation -
The owner of the function
- 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.
Teva’s Equal Employment Opportunity Commitment