Process Validation Expert
vor 2 Wochen
The MSAT DP within the Fill & Finish Departmentleads and manages all the Drug Products site technical activitieswithin our client site in Aubonne to ensure the supply of NewBiologic Entities (NBEs) and the business continuity andProduct-Lifecycle activities on legacy products portfolio, incompliance with specifications, registration and GMPrequirements.
To evolve in this environment, weare looking for our next Process Validation Expert.
You will be responsiblefor:
- Technical transfer, processvalidation, IMP & commercial manufacturing campaign activitiescoordination
- Coordination of productiontroubleshooting/investigation and potential support, ifrequired
- Coordination with PharmaceuticalDevelopment entities
- Training of Aubonne sitepersonnel
- Internal / Externalaudits
Functie-eisen
Whoyou are:
- Degree in Biotechnology,Process Engineering, Pharmacy or related subject
- Minimum of 3 years of experience in technologytransfer, in R&D/Manufacturing environment
- Demonstrated success record in leadingprojects, using project management tools and processimprovements
- Sound awareness ofbio-pharmaceutical business
- Sound awareness ofGMP related issues and Health Authorities'requirements
- Fluent in French andEnglish
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Process Validation Expert
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Aubonne, Schweiz Randstad VollzeitThe MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP...
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