Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Quality Analyst - Tapi

Teva Pharmaceuticals
Teva Pharmaceuticals
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.