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Quality Analyst I

Date: Nov 23, 2022

Location: Bangalore, IN, 560052

Company: Teva Pharmaceuticals

Who are we?

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

 

  • Plan, conduct and mange Internal audits (Study In process & Retrospective, System Audit) and Vendor audits as per the plan in compliance with SOPs, ICH-GCP, Protocol and applicable GxP standards/ regulations.
  • Preparation of audit reports for the audits conducted and release the audit report to auditee.
  • Aid in continuous improvement of quality management system. Assist seniors in team in maintaining all QA correspondence.
  • Preparation/Review of SOPs.
  • Assess suitability of responses to audit findings and negotiate suitable actions needed to satisfactorily resolve audit findings.
  • Review of deviations and CAPA plans and follow-up CAPA plans and ensure for its implementation and closer.
  • Assist in preparation of the facility for client/sponsor audits and regulatory inspection
  • Perform the reconciliation of Project and Non-project related documents and send for archival
  • Review the equipment calibration/validation records
  • To perform QA activities in other departments on need basis and assist QA staff as and when required.
  • Review of clinical development document and data management for internal consistency.
  • Preparation of standard operating procedures related to the Clinical development and data management quality assurance    department.
  • Conducting site audit, facility and quality system audits
  • Review of edit check plan and edit check software program (User acceptance testing).
  • Review the validated clinical trial data to ensure consistency, integrity and accuracy based on project specific requirement.
  • Review of data base design and medical coding.

Qualifications

2-3 Years of experience in Clinical QA activities in BA/BE Studies

Function

Quality

Sub Function

R&D Quality

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided 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.