Teva Pharmaceuticals Pharma Specialist Jobs – Chemistry Apply Online
Quality Sr Specialist
Date: Sep 9, 2024
Location: Bangalore, India, 560052
Company: Teva Pharmaceuticals
Job Id: 57983
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
- Ensures that the review of CMC documentation is completed in a 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 retrieval of data from the Quality and regulatory databases and systems.
- 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 the 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. 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 personnel located globally for arranging required documents and query responses.
- Escalation of issues to Supervisor, Group Leader, Manager Global Quality GBS.
- Contemporaneous updation of SharePoint database.
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 retrieval of data from 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 database.
C. Quality Management Systems:
- Initiate the process of change controls and deviations.
- Preparation of local SOPs and related documents.
- Participate in self-inspection processes.
D. Performance Management
- Participate in continuous process improvement projects to improve the efficiency of the unit.
E. Training
- Prepare the Training Materials for GMP training and on-the-job training.
- Impart training on procedures as needed.
F. Miscellaneous Support
- Any other tasks assigned by the management for the 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’s Degree in Pharmacy or other natural sciences, or MSc in Chemistry.
- Basic knowledge of worldwide cGxP regulations.
- Good English language skills; other language skills could be helpful.
- Good communication skills.
- Basic knowledge of Computerized Systems. Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya, etc.) would be advantageous.
- Basic understanding of manufacturing, QC, and Contract manufacturing processes.
- Engagement to drive improvements and ability to manage complexity.
- Hands-on experience in Analytical Method development, Method Validation for API and FP of different analytical methods (e.g., Assay, impurities, dissolution, etc.) & Stability Studies.
- Hands-on experience in Review of Instrument/Equipment qualification records.
- Basic knowledge/hands-on experience of review of BMR.
- Basic knowledge/hands-on experience in Product Quality Reviews.
Reports To: Group Leader, Quality Assurance.
Link to Original Notification to apply
Keywords: Quality Sr Specialist, Teva Pharmaceuticals, Job Posting. Teva Pharmaceuticals Pharma Specialist Jobs – Chemistry Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
