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Quality Control Consultant - German Speaking

Stuttgart, Deutschland

  • Gehalt: Dependent on experience
  • Auftragstyp: Vertrag
  • Eingestellt am: 27/03/2018
  • Kontaktname: Frankie Cunningham
  • Kontakt Nummer: 01892 612612
  • Ref: 3265

Tätigkeitsbeschreibung

Quality Control Consultant

  • Our client are looking for someone with a minimum of 8 years QC experience for development projects, especially for late stage phase of new active substances (NCE)
  • Fundamental GMP understanding
  • Excellent knowledge on requirements (ICH, EMA, ANVISA) for analytical method validation, specifications, stability testing, PPQ (changes of analytical methods and specification before and after PPQ and its impact on the project)

Experience in:

  • Reference standard qualification
  • Specification setting for MAA for starting materials and intermediates incl. justification of specification,
  • Setting up fate and purge studies
  • Analytical method transfer from development to production
  • Expertise in key methods: GC, HPLC, LC-MS, PSD (laser diffraction)
  • Fluent English and German (written and spoken)
  • Experienced in providing technical leadership and trainings
  • Experienced in colaboration with CMOs (Chinese CMO's would be an advantage)

 

If this role is of interest to you please make an application by either completing the form below or contacting me directly on frankie.cunningham@hobsonprior.com or +44 (0) 1892 612 612