ID EXISTS
POS 2772
Status 5
DJM 1

Commissioning Verificiation & Qualification Execution Lead

Beschreibung: For one of our Swiss Pharma Biotech clients we are seeking freelance support as: Commissioning Verificiation & Qualification Execution Lead (M/F)
Tasks:
  • Leading and coordinating a verification/qualification program, incorporating black utilities, clean utilities, HVAC and cleanrooms, upstream and downstream processing, including CIP and SIP
  • Generation of CVQ change controls and drive their timely closure
  • Maintenance of a clean and safe working environment by enforcing procedures, policies, and regulations
  • Generation of method statements, risk assessments and permit preparation for responsible areas to handover to end users
  • Assisting in investigations of process equipment, utility systems, and control systems, as well as safety incidents
  • Implementation of CVQ strategies as set out by the head CVQ
Qualification:
  • BSc/MSc in engineering, biotech and/or pharma process
  • Profound experience in commissioning/qualification of USP/DSP facilities, including all utilities (black and clean) within the pharmaceutical/biotech industry
  • Technical knowledge of utilities, USP, DSP equipment, biotech processes, CIP/SIP
  • Working knowledge of Swissmedic, EU and FDA regulations
  • Knowledge of regulations and standards affecting biotech products
  • Must Have: Business fluency in German and English
Bemerkungen: WANTED: Commissioning Verificiation & Qualification Execution Lead (M/F). Contact Janina.Draeger@k-recruiting.com or +49 (0) 89 18 90 998 47. Skills: Biotech, English, FDA (USA: Food and Drug Administration), German, HVAC (heating, ventilating, and air conditioning), Pharma, Qualification & Validation

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