QC Scientist at Pharming Group

The Quality Control department is responsible for the release testing of products. Release testing is outsourced to several contract partners. The main task of the QC Scientist will be management of current and new analytical test methods to support release of product for commercial and/or clinical purposes. This includes managing contract partners, trouble shooting, validation and transfer of analytical methods.

Main duties and responsibilities:

  • Management of QC testing:
    • Contact person for QC testing of starting materials, DS and DP outsourced at CLOs/CMOs
    • Troubleshooting, monitoring/qualification of critical materials and reference standards Analytical Life Cycle Management
    • Validation and transfer
  • QC representation in projects:
    • Advice and contribute in developing/evaluating analytical methods, specifications, stability studies
    • Coordinate/execute all QC tasks within the project

Qualifications:

  • HBO/BSc/MSc in Life Science or similar
  • Good knowledge of GMP and hands on experience with guidelines (FDA, EMA and ICH)
  • Experienced in setting up validations and or transfers of analytical methods
  • Experience in working in a QC routine production environment and GMP requirements for analytical methods
  • Experience with evaluation and setting up SST and acceptance criteria

Skills:

  • Good knowledge of English, both in word and writing
  • Effective communication
  • Teamwork and coordinating skills
  • Accurate and flexible
  • Decisive and pro-active

Whom to contact at Leiden Bio Science Park?

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