ID EXISTS
POS 4622
Status 5
DJM 1

Lab System Qualification Specialist

Beschreibung: For one of our Swiss clients in Basel we are seeking temporary support as: Lab System Qualification Specialist (M/W/D)
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Key responsibilities:
  • Support the GMP compliant qualification of category B and C laboratory equipment for the Quality Control labs (e.g. HPLC, CE, UV, iCIEF, Subvisible Particles, Physical Tests) over the whole lifecycle from planning of new instrument qualification activities based on demand until the decommissioning
  • Definition of user requirement specifications, performing of Risk Analyses, defining and performing of qualification tests (IOPQ) and GMP compliant test documentation
  • Authoring, reviewing and approval of qualification documentation and SOPs in the document management system
  • Performing of Computerized Systems Validation (CSV) to ensure Data Integrity and Electronic Record & Electronic Signature requirements according to 21 CFR Part 11
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Key requirements:
  • Start: asap, latest July // Duration: 6 months // Capacity: fulltime
  • Scientific education e.g. certified lab technician or BSc or MSc Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field or IT background with several years’ experience in the GMP environment
  • Experienced in qualification of commercial off-the shelf laboratory equipment and CSV
  • Strong analytical thinking and problem solving abilities, high attention to detail while being able to pragmatically focus on the critical tasks
  • Experience working in a cGMP-regulated environment
  • Experience with Quality control specific software like TrackWise or EMPOWER advantageous
  • Excellent communication also across departments and inter-personal skills; Strong team player
  • Ability to work independently and self-motivated.
  • Good knowledge of written and spoken English
Bemerkungen: WANTED: Lab System Qualification Specialist (M/F/D). In case of interest please contact msp@k-recruiting.com or +41 71 577 27 41 Skills: English, GCLP (Good clinical laboratory practice), German, GMP (Good Manufacturing Practice), HPLC (High-performance liquid chromatography)
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Interesse geweckt?
Auf geht's!
Beginn: asap, latest March
Laufzeit: 12 months
Einsatzort: Basel
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