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Quality Control Analyst

Date: Nov 19, 2021

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!

Purpose

 

Developing analysis methods and performing method validations (R&D activities). Initiating and working independently on (Quality improving) projects. Performing and reviewing routine and non-routine analyzes. Start-up, performing and timely completion of Trackwise records. 

Contract

We offer a 1 year full-time contract.

Job Description

1. Set up and contribute to improving the quality level such as:

  • Developing, executing, review and checking and reporting microbiological validations  (R&D microbiological analysis and product development)
  • Initiating and implementing quality improvement projects
  • Introducing new method/equipment (including training, writing Sop’s etc.)

2. Ensure timely and correct execution and review of routine and non-routine analyzes according to procedure for determining the quality and composition of samples, as well as microbiological support of production departments including: analyzing primary packaging materials, raw materials, in-process samples and (non-)sterile end products (including stability studies) for the presence of (pathogenic) micro-organisms and endotoxins.

3. Coaching and guiding analyst of the department in carrying out the work:

  • Microbiological supporting analyst and laboratory technicians
  • Solving analysis problems
  • Assessing, interpreting and reporting on research results
  • Maintaining and extending GLP and GMP standards

4. Drafting and review internal and external regulations on functionality and advising management on feasibility of analysis methods

5. Drafting of Trend reports such as Environmental and Personnel monitoring, Utility monitoring, Microbial testing and Microbial identification

6. Coordination/planning of activities with various internal departments regarding microbiology and microbiological product and process validations

7. Start-up, performing and timely completion of Trackwise deviations reports (gDR), Laboratory  investigations (gLIR), corrective and preventative actions (gCAPA) and changes (gCCM)

8. Maintaining contact with internal and external customers

Qualifications

  • Education: at least HBO of Academical level in microbiology or similar
  • At least 3 years of experience in microbiology and within a lab
  • Knowledge of GMP and GLP is a must
  • Experience with LIMS (Laboratory information management system) is a must
  • Preferable Dutch, written & spoken English is a must
  • Softs skills: team player, strong can-do mentality, attention to detail, sense of urgency and excellent execution

Function

Quality

Sub Function

Manufacturing Quality Control

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.