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Validation Expert

Date: Jan 12, 2019

Location: Haarlem, NL, 2031 GA

Company: Teva Pharmaceuticals

Company Info

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

Within the MS&T (Manufacturing Science and Technology) department we are looking for a Process Validation and Improvement Expert.

 

You are a subject matter expert, responsible for planning and execution of process/cleaning validations, media fills, line/operator qualification, as well as process improvement and product robustness initiatives. You will work in dynamic project teams responsible for new project introductions, process improvements and remediations to meet current regulatory requirements, and will ensure that the executions are in line with international and TEVA global guidelines.

 

  • You will carry out risk assessment, and prepare validation plans, protocols, execution of experiments and reporting of the work.
  • Participate in the execution of the respective validation activities, evaluate the results and prepare reports from them.
  • You are part of operational excellence and product robustness teams, responsible for critical assessment of processes and design of improvement plans, continued process verification.
  • Keep up-to-date with regulatory guidelines on process validation requirements.
  • In addition, you take part in many other activities required for optimal quality of validation activities.

Qualifications

  • MSc in bioprocess engineering/technology, pharmacy, chemistry or similar
  • At least 2 years’ experience in a cGMP environment
  • Experience with process improvement/validation or quality assurance
  • Working knowledge of FDA/EU GMP guidelines
  • Good command of the English language
  • Team player with pro-active approach.

 

This is a dynamic challenging position with possibilities for growth within our company.

Function

Manufacturing

Sub Function

Technical Transfer

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.