Job Title: Quality Specialist II
📅 Date: September 18, 2025
📍 Location: Bangalore, India, 560064
🏢 Company: Teva Pharmaceuticals
🆔 Job ID: 64031
🌍 Who We Are
At Teva Pharmaceuticals, we’re united by a single mission — to make good health more affordable and accessible for millions around the world. As the world’s leading manufacturer of generic medicines, our products are trusted by 200 million people daily. We’re featured on the World Health Organization’s Essential Medicines List, and with a diverse team across 60 countries, we continue to innovate and improve healthcare globally.
💼 The Opportunity
As a Quality Specialist II, you will be responsible for reviewing CMC documentation, ensuring timely and compliant review as per Teva’s corporate standards. The role involves compilation of Product Quality Reviews (PQRs) / Annual Product Reviews (APRs), liaising with global manufacturing sites, and driving continuous quality improvement across products and processes.
You will collaborate with Teva Manufacturing Sites, Global Quality Units, and Commercial affiliates to maintain compliance and deliver high-quality outcomes.
🧠 Key Responsibilities
🔹 CMC Documentation Review
Review CMC documents to ensure compliance with Teva standards.
Review Method Development & Validation protocols/reports and Stability Study protocols/reports.
Review Instrument/Equipment Qualification records and Batch Manufacturing Records (BMRs).
Liaise with global QA/QC teams and contracting units to gather documents and query responses.
Escalate critical issues to supervisors or managers.
Ensure contemporaneous data updates in SharePoint.
🔹 PQR / APR Compilation
Compile high-quality Annual Product Reviews (APRs) and Product Quality Reviews (PQRs).
Retrieve and validate data from Quality and Regulatory databases.
Liaise with third-party manufacturers and QA personnel globally for data collection.
Follow up with Contract Manufacturing Organizations (CMOs) for timely data receipt.
Review CMO quotations, initiate PR/PO for QP’s approval, and maintain PQR checklists.
Schedule and track PQR progress in SharePoint.
Escalate PQR issues to leadership as required.
🔹 Quality Management Systems (QMS)
Initiate and manage Change Controls and Deviations.
Prepare and maintain Standard Operating Procedures (SOPs).
Participate in self-inspections and ensure process compliance.
🔹 Performance & Process Improvement
Contribute to continuous improvement projects to enhance unit efficiency.
Monitor performance metrics and support corrective action initiatives.
🔹 Training & Development
Develop GMP training materials and conduct on-the-job training.
Deliver procedural training sessions as required.
🔹 Miscellaneous Support
Execute any additional tasks assigned by management to ensure smooth operations.
🎓 Your Experience and Qualifications
Education:
Master’s or Bachelor’s degree in Pharmacy or Natural Sciences.
Experience:
2–8 years in Quality Assurance (QA) or Quality Control (QC) in the pharmaceutical industry.
Technical Skills:
Strong knowledge of global cGxP regulations.
Hands-on experience in:
Analytical Method Development & Validation (API and FP)
Stability Studies
Instrument/Equipment Qualification Reviews
Batch Manufacturing Record (BMR) Reviews
Product Quality Reviews (PQRs)
Familiarity with systems such as TrackWise, SAP, LIMS, Global Insights, Glorya, etc.
Proficiency in MS Office and data management tools.
Soft Skills:
Strong English communication skills (verbal & written).
Additional language skills are an advantage.
Excellent attention to detail, organizational, and analytical abilities.
Ability to manage complexity and drive process improvements.
⚖️ Equal Employment Opportunity Commitment
Teva Pharmaceuticals is an equal opportunity employer. We ensure all qualified applicants receive fair consideration without regard to age, race, religion, gender, disability, pregnancy, sexual orientation, gender identity, national origin, or any other legally protected status.
We are committed to fostering a diverse, inclusive, and accessible workplace. If you require accommodation during the recruitment process, please notify us — all information will remain confidential.
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