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Quality Sr Specialist
Watson Pharama
posted 1d ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
- 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 personnel located globally for data collection required for compilation of APRs/ PQRs
- 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
How you ll spend your day
A. 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
B. 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
C. Performance Management
- Participate in continuous process improvement projects to improve efficiency of the unit
D. Training
- Prepare the Training Materials for GMP training and on the job training.
- Imparts training on procedures as needed.
E. 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
- 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 PQR compilation would be preferre
Employment Type: Full Time, Permanent
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based on 8 employees
Strict timing
Monday to Friday
Within city
Day Shift
Watson Pharama Benefits
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