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Quality Analyst - Tapi

7-8 years
Not Disclosed
10 Sept. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Quality Analyst – TAPI

Date Posted: August 19, 2025
Location: Gajraula, India, 244235
Company: Teva Pharmaceuticals
Job ID: 61364


About Teva TAPI

TAPI (Teva Active Pharmaceutical Ingredients) is the leading global supplier of active pharmaceutical ingredients, with the industry’s broadest portfolio of over 350 API products. Supporting 80% of the world’s top 50 pharmaceutical companies, TAPI brings more than 80 years of trusted expertise to the generic API industry.

  • Employees: 4,000+ professionals

  • Sites: 14 worldwide (Italy, Hungary, Czech Republic, Croatia, Israel, Mexico, India)

  • Strengths: R&D investment, regulatory expertise, innovative technologies, and exceptional customer service


Key Responsibilities

1. Documentation & Compliance

  • Review all documentation before batch release/rejection (batch records, test results, deviations, LIR, OOS, CAPA, validation, COA, Change Controls).

  • Ensure timely compliance and resolution of errors/deviations in executed documents.

  • Verify adherence to batch manufacturing & packaging requirements.

2. Corrective & Preventive Actions (CAPA)

  • Review, approve, and monitor CAPAs to ensure timely closure.

  • Assess effectiveness of corrective and preventive measures.

  • Participate in investigations and ensure proper closure with corrective actions.

3. Quality Communication & Issue Resolution

  • Initiate NTM (Notice to Management) for critical quality/compliance issues.

  • Act as quality interface with internal teams and external customers.

  • Support material/product transfers between sites.

4. Shop Floor & Operational Oversight

  • Observe, review, and audit shop floor activities.

  • Provide investigation support and ensure presence on the shop floor when required.

5. Shipment & Regulatory Compliance

  • Coordinate shipment, delivery, and receipt of materials to meet regulatory requirements.

  • Approve shipping routes, validate processes, and investigate temperature excursions.

6. R&D & Tech Transfer Support

  • Oversee product development and technology transfer at site level.

  • Support regulatory submissions for Market Authorization (MA).

7. Validation & Stability

  • Review data related to validation (manufacturing, packaging, testing, stability, sourcing, deviations).

  • Evaluate cleaning validation and verification processes.

  • Review validation protocols and reports for manufacturing, packaging, and Continuous Process Verification (CPV).

  • Assess stability requirements during validation.


Qualifications & Experience

  • Education: M.Sc. Chemistry, B. Pharm, M. Pharm, or B. Tech (Chemical).

  • Experience: 7–12 years (API manufacturing only).


Employee Application Instructions

  • Current Teva employees should apply via the Internal Career Site (Employee Central).

  • Priority will be given to internal applicants.

  • For access issues, contact your local HR/IT partner.


Equal Employment Opportunity

Teva Pharmaceuticals is an equal opportunity employer, committed to diversity and inclusion. Employment decisions are made without regard to:
Age, race, religion, gender, disability, pregnancy, medical condition, sexual orientation, gender identity/expression, veteran status, national/ethnic origin, or any other protected status.

Applicants needing accommodation during the recruitment process will be supported confidentially.