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Quality Analyst Iii

10-11 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 Analyst III
Date: Feb 5, 2025
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job Id: 60065

Company Overview

Teva Pharmaceuticals is on a mission to make good health more affordable and accessible, impacting millions of lives worldwide. We are the leading global manufacturer of generic medicines, producing many essential medicines listed by the World Health Organization. Our goal is to continue improving lives by ensuring the accessibility of life-saving medicines, impacting over 200 million people daily. We’re looking for passionate individuals to help us make a difference.


Job Responsibilities

  1. Quality Management System (QMS) Compliance

    • Follow the Quality Management System of the External Manufacturing and Supply Operations (EMSO) organization, ensuring all job functions are aligned with it.
  2. Deviation, OOS/OOT Management

    • Review and manage deviations, out-of-specifications (OOS), and out-of-trend (OOT) issues related to formulations supplied to EMSO.
  3. Global and Regional Project Management

    • Handle global and regional projects, ensuring timely and compliant outcomes within the quality framework.
  4. Change Control System Management

    • Oversee the life cycle management of the Change Control system, ensuring efficient and timely execution.
  5. Standard Operating Procedure (SOP) Preparation

    • Prepare and review Standard Operating Procedures (SOPs) related to quality and regulatory practices.
  6. Training Management

    • Coordinate and manage training programs to ensure all team members are up-to-date on quality and regulatory processes.
  7. Document Management

    • Ensure all quality-related documents are accurately managed, including batch records, and timely updates on QMS documents.
  8. Batch Record Review

    • Review and approve batch records associated with formulations, ensuring compliance with quality standards.

Qualifications

  • Education:

    • M.Sc (Sciences) or B.Pharm / M.Pharm
  • Experience:

    • Minimum of 10 years of experience in Quality Assurance within the pharmaceutical industry.
  • Knowledge:

    • Strong understanding of cGMP, Quality Management Systems (QMS), and pharmaceutical manufacturing processes.
    • In-depth knowledge of Compliance Standards and Regulations, specifically for the US, EU, UK, and Canada markets.

Reports To

Associate Director, Quality Assurance


Already Working at TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central." Your application will be given priority, and you will also have access to opportunities exclusive to Teva employees. For any access issues, please contact your local HR or IT partner.


Teva Pharmaceuticals is an equal opportunity employer, committed to fostering a diverse and inclusive workplace.