Cleaning Validation Expert

vor 2 Wochen

Aubonne, Schweiz Randstad Vollzeit
Jobdescription
For ourclient Merck in Aubonne, we are looking for a Cleaning ValidationExpert (m/f/d) for a period of 12 months.
 

Your Role :
 
  • Coordinate cleaning validation andmonitoring activities in line with the life cycle of amanufacturing process for biotech manufacturingequipment
  • Establish and execute validationprotocols and reports for cleaningvalidation
  • Ensure reliability and conformity ofvalidation and control activities in line with internal andregulatory procedures and guidelines
  • Providetechnical support to cleaning activities associated with themanufacturing process.
  • Perform successful andon time resolution of incidents and deviations related to cleaningvalidation exercises (Investigates and conductstroubleshooting/root cause analysis of cleaning related incidents,deviations and cleaning out of specificationresults)
  • Support the periodic process reviewand etablish documentation relation to control of the process (PCS, sampling plans and commercial panel testing)
  • Lead the enhancement of cleaningpractices
  • Share best practices and trainteams
  • Be cleaning Expert during audits andinspections
 
Who YouAre:
  • Bachelor's or Master's Degree in Science,Pharmacy or Engineering.
  • Minimum of 5 years ofprofessional experiences in cleaning validation in thepharmaceutical and biotechnologyindustries.
  • Fluent in english andfrench
  • Proficient knowledge of cleaningvalidation, continuous process improvement and troubleshootingprocesses.
  • Proficient time management skills,planning and organization capabilities.
  • Provenleadership & teamwork skills, self starter, results orientedand build and maintain strong relationships with multiplegroups.
  • Proficient in RiskAssessment/Management Proven assessment, analytical andproblem-solving skills.
  • Proficient presentationskills and Technical Writing/Oral communication skills (English)Proficient in cGMP's, and FDA Regulations as it applies topharmaceutical industry.

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