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Senior Sterility Assurance Specialist

Date:  Jan 25, 2023
Location: 

Amsterdam, Netherlands, 1019

Company:  Teva Pharmaceuticals
Job Id:  43976

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!

Location of the role

Amsterdam (NL), Haarlem (NL) or Runcorn (UK)

What will you do?

As an Senior Sterility Assurance Specialist you will ensure that the Complex Manufacturing & Supply Operations (CMSO) Quality Compliance System is in place, securing compliance of activities, quality risk management, escalation of risks, and continuous improvement. 

Your role will include strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at Teva sites and to improve sterility assurance. You will also interact across the matrix organization specifically with Teva Global Quality Compliance, Manufacturing Science & Technology, Research & Development, Supply Chain Operations, and other network manufacturing supply sites.

You will collaborate with the CMSO sites to improve and enhance GMP compliance, to solve quality-related product and system issues, including those related to sterility assurance and identify areas of improvement for quality operational performance in accordance to Teva standards. Moreover, you will contribute to onsite Quality culture across the CMSO segment.

 

In this role, you will...

 

  • Engage in Corporate Standards Processes
  • Input, review, and endorse Complex Investigations
  • Support the Implementation of the Site Inspection Readiness Program
  • Evaluate and endorse the Site Inspection Readiness Program
  • Forward escalations to Regulators; i.e. Field Alert Reports (FARs) and Rapid Alert Notifications (RANs)
  • Support the development of Global Risk Assessment (GRA) Audits Corrective and Preventive Action Plan (CAPA)

Who are you?

You have an academic background in Chemistry, Pharmacy, Pharmaceutical Science, Microbiology or similar.
 

You will bring extensive experience working in a manufacturing environment within the Quality or Compliance department, with exposure to site operations. Experience working with technical and operational teams troubleshooting will be considerate a plus. 
 

You are a Microbiology / Sterility Assurance expert and have experience in Data Integrity management.
 

You have proven  experience in Compliance and Health Authority interactions. Working knowledge of audit and inspection management, response writing and CAPA management programs.
 

You will have Knowledge of local current and upcoming legislation and current Quality best practices. International experience will be an advantage.

What will we offer?

  • International and cross-functional career oppurtunities
  • Competitive salary
  • Electric company car or car allowance (or fully covered public transport contribution
  • A number of health benefits including like Accident Assurance and Income protection
  • Flexible working conditions with hybrid working policy
  • Competitive Pension
  • A very diverse International team

Function

Quality

Reports To

Senior Director, Quality Compliance CMSO

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.