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QA Qualification et Validation Expert (m / f / d)
RandstadCorsier-sur-Vevey, Vaud, CHIl y a 19 jours
Description de posteYou 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)
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.
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