Qa Operational

vor 1 Monat


Bern, Schweiz Gi Life Sciences Vollzeit

For our partner in biotechnology industry, Gi Life Science is looking for:

 

QA operational

(temporary position)

 

Your mission:

  • Support operational readiness of new product introduction

 

Your responsibilities:

  • Responsible for the daily support of the manufacturing area (USP and DSP), including compliance, KPI,
  • Schedule daily operational activities e.g. material staging, equipment daily checks
  • Support equipment qualification activities
  • Participation in the manufacturing of Upstream or Downstream manufacturing process operations
  • Involved in change management including authoring change controls
  • Involved in deviation management (deviations & CAPAs)
  • Lead root cause analysis investigations
  • Authoring Standard Operating Procedures (SOP’s) and Work Instructions (WIs)
  • Actively involved in process FMEAs and Risk Analysis meetings
  • Ensure required safety documents are in place for the operation of key process equipment
  • Involved in creation of training curricula and hands-on training of other team members

 

Your profile:

  • University degree in Pharmacy, chemistry or any relevant field
  • Experience in a similar position in a GMP environment
  • Fluent in English, French and/or german a plus
  • Shift work may be required

 

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