QA Qualification et Validation Expert

vor 3 Monaten

CorsiersurVevey, Schweiz Randstad Vollzeit
Jobdescription

An exciting new opportunity has arisen to joinus as Quality Assurance Qualification & Validation Engineer forour Biotech drug substance plant in Corsier-sur-Vevey.
As an integral member of the Quality Unit, you provide QAexpertise for Process Validation and AnalyticalValidation:

  • Youelaborate the qualification/validation strategies, review andapproval of protocols and reports, participates to risk analysis,identifies gap and purposes remediationplan
  • You act as Quality Subject Matter Experton specific topics and participate in risk assessments and handledeviations on these topics
  • You review and/orapprove qualification/validation documents, risk assessment, SOPsand take quality decisions according to companystandards

Theactivities of the QA Expert cover all qualification/validationphases from Basic Design until 1st use of equipment/rawmaterial.10. You ensure GMP compliance during all phases ofqualification/validation.

Functie-eisen
  • You have a university degree with at least5 years of experience in pharmaceutical quality environment
  • Proven experience in analytical methodsvalidation and manufacturing process validation
  • Strong communication and strong teamspirit
  • Good stressresistance
  • Fluent in French and English (oral& written)

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