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Quality Sr Specialist - Qa - Tapi

4-10 years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 Sr Specialist - QA - TAPI
Date: Feb 1, 2025
Location: Gwalior, India, 477117
Company: Teva Pharmaceuticals
Job Id: 59537


Company Overview:

TAPI (Teva Active Pharmaceutical Ingredients) is a global leader in supplying active pharmaceutical ingredients (APIs) and is the go-to supplier for 80% of the top 50 global pharmaceutical companies. With over 350 API products, TAPI has been a trusted name in the generic API industry for over 80 years. The company employs over 4,000 professionals across 14 sites worldwide, with state-of-the-art production facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Teva is committed to providing reliable customer service and maintaining strong leadership in the industry through expertise and innovation.


Position Overview:

The Quality Sr Specialist - QA is responsible for ensuring the quality management system is implemented and maintained effectively, managing documentation, validation processes, and ensuring compliance with regulatory requirements. This position plays a crucial role in ensuring product quality by overseeing quality metrics, validation documentation, and continuous improvement within the quality systems.


Key Responsibilities:

  1. Data Collection & Review:

    • Collect, compile, analyze, and review data for Annual Product Quality Review (APQR).
  2. Change Management:

    • Oversee the change management process, including generation, justification, impact assessment, modification, review, approval, and implementation of changes.
  3. Validation & Documentation:

    • Review and approve all documentation related to process validation, cleaning validation, and Continued Process Verification (CPV).
    • Manage the processing, modification, and archival of records.
    • Review and approve documentation associated with GMP (Good Manufacturing Practice) equipment qualifications (IQ, OQ, PQ).
  4. Quality Metrics & Compliance:

    • Track, trend, and report quality metrics for site, regional, and global review.
    • Ensure compliance with SOPs, corporate standards, and regulatory requirements.
  5. GMP Computerized System:

    • Review and approve documentation associated with the establishment and configuration of GMP computerized systems, including all lifecycle documents.
  6. Regulatory Support:

    • Assist Regulatory Affairs by supporting updates or changes to Market Authorizations.
  7. Training & Development:

    • Manage and track GMP training to support plant performance and quality departmental training.
  8. Validation Master Plan:

    • Review and approve the Validation Master Plan and associated documentation for process, system, equipment, and facility validations.

Experience & Qualifications:

  • Educational Requirements:

    • B.Sc or M.Sc in Chemistry or related field.
  • Experience:

    • 4 to 10 years of relevant experience in Quality Assurance, specifically in pharmaceutical or API manufacturing environments.

Reports To:

  • Manager, Quality Systems

Teva’s Equal Employment Opportunity Commitment:

Teva Pharmaceuticals is an equal opportunity employer. We provide employment opportunities without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally recognized status entitled to protection under applicable laws. We are committed to creating a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please let us know if you need any accommodations to support you through the recruitment and selection process. All information provided will be treated as confidential and used solely for ensuring an accessible candidate experience.


Interested candidates can apply through the Teva Pharmaceuticals career portal.

 

 

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