Teva Pharmaceuticals is hiring for the position of Quality Specialist II in Bangalore, India. The role focuses on pharmaceutical quality documentation, analytical method validation, stability studies, equipment qualification records, batch manufacturing record reviews, and Product Quality Reviews (PQRs) and Annual Product Reviews (APRs).
Candidates with 2–8 years of experience in pharmaceutical Quality Assurance (QA) or Quality Control (QC), along with relevant pharmacy or natural sciences qualifications, can review the eligibility requirements below.
Job Details
| Particulars | Details |
|---|---|
| Company | Teva Pharmaceuticals |
| Job Title | Quality Specialist II |
| Job Location | Bangalore, India |
| Experience | 2–8 years |
| Qualification | Master’s or Bachelor’s degree in Pharmacy or other natural sciences |
| Department | Quality |
| Industry | Pharmaceutical / Biopharmaceutical |
| Employment Type | Not mentioned |
Position: Quality Specialist II
The Quality Specialist II will support global quality operations by reviewing pharmaceutical quality documentation, compiling Product Quality Reviews and Annual Product Reviews, coordinating with manufacturing sites and quality teams, and recommending improvements to product quality.
Key Responsibilities
- Review Chemistry, Manufacturing and Controls (CMC) documentation within required timelines and in compliance with Teva corporate standards and applicable guidance.
- Review analytical method development and validation protocols and reports, along with stability protocols and reports.
- Review instrument and equipment qualification records.
- Review Batch Manufacturing Records (BMRs).
- Compile and approve Product Quality Reviews (PQRs) and Annual Product Reviews (APRs) in accordance with Teva’s quality management systems.
- Collect quality data from databases, regulatory systems, and manufacturing sites to prepare APRs and PQRs.
- Coordinate with third-party contract manufacturers, QA/QC teams, and technical support personnel across global locations.
- Communicate recommendations to manufacturing sites and quality units to support continuous improvement in product quality.
- Collaborate with manufacturing sites, Global Quality Units, commercial affiliates, and other quality teams to ensure timely and compliant review completion.
Eligibility and Qualifications
Candidates applying for the Teva Quality Specialist II job should meet the following requirements:
- Experience: 2–8 years in a pharmaceutical Quality Assurance or Quality Control function.
- Education: Master’s or Bachelor’s degree in Pharmacy or another natural science.
- Basic knowledge of worldwide current Good Manufacturing, Laboratory, and related Quality Practice (cGxP) regulations.
- Understanding of pharmaceutical manufacturing, QC, and contract manufacturing processes.
- Hands-on experience in analytical method development and validation for Active Pharmaceutical Ingredients (APIs) and finished products.
- Experience with stability studies and review of instrument/equipment qualification records.
- Basic knowledge or hands-on experience in reviewing Batch Manufacturing Records.
- Basic knowledge or hands-on experience in Product Quality Reviews.
Required Skills
- Analytical method development and validation, including assay, impurities, and dissolution testing.
- Stability study documentation and report review.
- Pharmaceutical quality documentation and compliance.
- Product Quality Review (PQR) and Annual Product Review (APR) compilation.
- Understanding of cGxP regulations and quality management systems.
- Computerised systems knowledge.
- Strong English communication skills.
- Ability to coordinate with global teams and contract manufacturing organisations.
- Continuous improvement mindset and ability to manage complexity.
Knowledge of Teva’s IT systems, including TrackWise, SAP, LIMS, Global Insights, and Glorya, is an advantage. Additional language skills may also be helpful.
