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Group Leader Quality Assurance

Company

Teva Pharmaceuticals
Address , West Chester, 19380, Pa
Employment type
Salary
Expires 2023-07-03
Posted at 1 year ago
Job Description

Group Leader Quality Assurance

Date: May 3, 2023
Location:West Chester, United States, 00000
Company: Teva Pharmaceuticals
Job Id: 48176

Who we are?

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity


The Quality Assurance Group Leader is responsible for coordinating activities for site level quality assurance activities related to facility & equipment in the production facility and/or quality control testing labs.



Essential Responsibilities

  • Review of manufacturing facility, and some QC testing laboratory, documentation related to equipment, utilities, metrology, etc.
  • Ensure activities are performed/completed using current Good Manufacturing Practices.
  • Support of manufacturing activities as QA OTF
  • Serve as Quality resource, representing QA on teams in support of assignments.
  • Provide feed-back/communication of any issues.
  • Support onboarding and retirement activities related to equipment and instrumentation
  • Participate/support regulatory agency filings, inspections, and internal audits, as needed.
  • Support product dispositioning activities
  • Ensure site alignment with corporate standards and cGMP guidelines and support complete Gap assessments to align with corporate standards
  • Review and approve of Calibration documents supporting the manufacturing facility and quality control laboratory.
  • Review and approval of (but not limited to): Change controls, deviations, CAPAs/effectiveness checks, and laboratory investigations in TrackWise.
  • Review and approve corrective work orders in CMMS
  • Responsible for performing periodic reviews to ensure alignment with current procedures.
  • Review and approve of Validation, Engineering and Automation documents supporting the manufacturing facility

How you’ll spend your day

Your experience and qualifications

Qualifications
  • Knowledge in Quality Compliance (cGMP/ICHIFDAIUSP/EP policies/guidelines) required. Minimum 5 years QA experience in development of Biopharmaceutical/Biologics/Large Molecule products preferred.
  • Basic experience with SAP, Trackwise, EDMS, CMMS
  • Proficient with Microsoft Word and Excel.
  • Familiar with biopharmaceutical operations and cGMP documentation practices.
  • BS/BA or Undergraduate degree in applicable disciple preferably life science.

Enjoy a more rewarding choice

Make a difference with Teva Pharmaceuticals

Reports To

In process of validation

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.