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Qualified Person

Date: Oct 13, 2021

Location: Haarlem, NL, 2031 GA

Company: Teva Pharmaceuticals

Our company

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!

Your role

 

Ensuring that the entire process of development, production and control during the entire "life cycle" of a medicinal product is carried out in accordance with the applicable laws, regulations and the registration dossier.

Your responsibilities

Release of products from the Operations Department, in order to market products that comply with applicable laws, regulations and the registration dossier:

  • Initiate and assess quality investigations, in order to be able to make a decision about approval or rejection, making improvement proposals and ensuring the implementation of approved improvement proposals
  • Review and timely completion of deviation/investigation reports (gDR/gLIR))
  • Initiate quality improvement processes aimed at controlling risks in production processes of the departments within Operations
  • Authorize performed on-going stability study
  • Authorize Product Quality Reviews
  • Preparing, supervising and handling (follow-up) inspections by governments and customers

Also dealing with calamities, complaints handling, including:

  • Coordination of complaint handling of products with attention to investigating the root cause of the complaint, drawing up and implementing points for improvement and monitoring the lead time of the complaint handling
  • Coordinating recalls and making proposals to put stock on hold
  • Developing and maintaining external contacts (network) with regard to the area of ​​responsibility and maintaining QA contacts and participating in processes for Third Party Manufacturing / TEVA Product Transfers

Functional leadership of QA employees, including:

  • Ensure the introduction of structured working methods
  • Make proposals for organizational structure, staffing and training for employees
  • Performing self-inspections in the production, storage and distribution departments involved

Your profile

  • A completed study (MSc) in pharmacy, pharmaceutical chemistry, biology or pharmaceutical chemistry and technology
  • Extensive experience with aseptic production processes
  • Familiar with automated processes
  • Good knowledge of pharmaceutical laws and regulations (EU and US)
  • Good knowledge of analytical methods
  • Decisive and persuasive
  • Result-oriented (Sense of Urgency – Excellent execution)
  • Transparency (Clarity – Approachable and engaging)

Pre-employment screening

Teva will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.

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.