QA Qualification et Validation Expert
vor 3 Wochen
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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Corsier-sur-vevey, Schweiz Randstad VollzeitAn exciting new opportunity has arisen to join us as Quality Assurance Qualification & Validation Engineer for our Biotech drug substance plant in Corsier-sur-Vevey.As an integral member of the Quality Unit, you provide QA expertise for Process Validation and Analytical Validation: You elaborate the qualification/validation strategies, review and approval...
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Corsier-sur-vevey, Schweiz Randstad VollzeitAn exciting new opportunity has arisen to join us as Quality Assurance Qualification & Validation Engineer for our Biotech drug substance plant in Corsier-sur-Vevey.As an integral member of the Quality Unit, you provide QA expertise for Process Validation and Analytical Validation: You elaborate the qualification/validation strategies, review and approval...
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