Process Validation Expert

vor 1 Monat


Aubonne VD, Waadt, Schweiz Randstad Vollzeit

The 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 requirements.

To evolve in this environment, we are looking for our next Process Validation Expert.

You will be responsible for:

Technical transfer, process validation, IMP & commercial manufacturing campaign activities coordination Coordination of production troubleshooting/investigation and potential support, if requiredCoordination with Pharmaceutical Development entitiesTraining of Aubonne site personnelInternal / External audits qualifications Who you are: Degree in Biotechnology, Process Engineering, Pharmacy or related subject Minimum of 3 years of experience in technology transfer, in R&D/Manufacturing environment Demonstrated success record in leading projects, using project management tools and process improvementsSound awareness of bio-pharmaceutical businessSound awareness of GMP related issues and Health Authorities' requirementsFluent in French and English
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