Biologics - Group Leader Quality Assurance

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:

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

Your experience and qualifications

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

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.