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Senior Scientist GMP QC Lab

Solliciteer hier

Sophie Steels
Career Manager


Solliciteer hier

Sophie Steels
Career Manager



Sophie Steels
Career Manager


Jobomschrijving

  • Perform your activities in GMP QC Lab according to the Quality System
  • Represent the GMP QC Lab in cross departmental teams and in external contacts as subject matter expert
  • Be responsible for the technology transfer of analytical methods from the  GMP Unit to a Receiving Unit
  • Perform method validation according to current GMP regulations, ICH guidelines and Pharmacopeia. You perform method life cycle management and keep oversight over methods performed on different sites
  • Assist in global expansion of a commercial product and you adapt the analytical methods based on gap assessments to the requirements of local authorities while still maintaining the
  • validated status of the analytical method
  • Perform technical review of analytical results (such as SEC, RPC, IEX-HPLC, CGE, UV spectrometry, compendial methods, and potency assays (Biacore), assist and guide the Associate Scientist in technical problem solving and conduct OOx-investigations if required
  • Follow up on trending data and define appropriate actions if required
  • Organize trainings as subject matter expert (on methods, laboratory systems)
  • Be responsible for the coordination, execution and the quality control of the activities executed by the GMP QC Lab
  • Write, review and finalize the study plans and the final reports for the release testing, stability studies, method validation and any other studies performed in the GMP laboratory
  • Write and follow-up all quality related documents such as change controls, deviations, …


Profiel


  • PhD with at least a first experience within the pharma industry or Master with 7-10 years of relevant experience
  • You have experience in physico-chemical analysis and/or potency testing of proteins
  • Experience with technology transfer, method life cycle management, stability studies and release testing in a commercial setting is an asset
  • Experience with GMP guidelines and a GMP working environment
  • Knowledge of ICH and Pharmacopeia
  • MS Office: proficient level
  • Fluent English, written and spoken, fluent in Dutch preferred
  • You combine technical expertise with good people management skills
  • Team player, enthusiastic, independent and self-motivated
  • Excellent communication and writing skills are required
  • Sense for initiative, quality, accuracy and detail


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