Job Title:
Quality Specialist II
Date Posted:
18 Sept 2025
Location:
Bangalore, India, 560064
Company:
Teva Pharmaceuticals
Job ID:
64031
Company Overview:
Teva Pharmaceuticals is a global leader in generic and innovative medicines, committed to making healthcare more affordable and accessible. Teva operates across nearly 60 countries and is a trusted producer of many products on the WHO Essential Medicines List.
Role Overview:
The Quality Specialist II ensures the timely and compliant review of CMC documentation, method development/validation, stability studies, and product quality reviews in accordance with Teva Corporate standards. The role involves coordination with global manufacturing sites, R&D units, and QA/QC personnel to maintain high-quality standards and support continuous improvement initiatives.
Key Responsibilities:
Review of CMC Documentation:
Review Method Development/Validation Protocols & Reports.
Review Stability Study Protocols, Reports, and Grids.
Review Instrument/Equipment Qualification records.
Review Batch Manufacturing Records (BMR).
Escalate issues to Supervisor, Group Leader, or Manager as needed.
Data Collection & Compilation of Product Quality Reviews:
Compile high-quality Annual Product Reviews (APRs) / Product Quality Reviews (PQRs) for products from multiple manufacturing sites.
Retrieve data from Quality and Regulatory databases and systems.
Liaise with third-party contract manufacturers, QA/QC personnel, and global teams to ensure timely data collection.
Follow up with CMOs for timely receipt of data.
Initiate PR/PO for QP approval of quotations received from CMOs.
Fill PQR receipt checklists and schedule PQRs in SharePoint.
Update SharePoint database contemporaneously.
Quality Management Systems:
Initiate and manage change controls and deviations.
Prepare local SOPs and related documentation.
Participate in self-inspection processes.
Performance & Process Improvement:
Participate in continuous process improvement projects to enhance unit efficiency.
Training:
Prepare training materials for GMP and on-the-job training.
Conduct training sessions as needed.
Miscellaneous Support:
Perform other tasks assigned by management to ensure smooth team functioning.
Experience and Qualifications:
Education: Master’s Degree or Bachelor’s Degree in Pharmacy or other natural sciences.
Experience: 2–8 years in QA/QC within the pharmaceutical industry.
Skills & Knowledge:
Basic knowledge of worldwide cGxP regulations.
Good English communication skills; other languages helpful.
Knowledge of computer systems (TrackWise, SAP, LIMS, Global Insights, Glorya).
Understanding of manufacturing, QC, and contract manufacturing processes.
Hands-on experience in analytical method development, method validation for APIs and finished products, and stability studies.
Experience reviewing Instrument/Equipment qualification records, BMRs, and Product Quality Reviews.
Engagement to drive improvements and manage complexity.
Equal Opportunity Statement:
Teva Pharmaceuticals is committed to equal employment opportunity. Employment decisions are based on merit, qualifications, and business requirements without regard to age, race, creed, color, religion, sex, disability, sexual orientation, gender identity, or other legally protected status. Reasonable accommodations are provided to support candidates during the recruitment process.
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