Process Validation Expert

vor 4 Monaten

Aubonne, Schweiz Randstad Vollzeit
Jobdescription

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 to ensure thecoordination of production troubleshooting and Annex 1 projectrelated.

You will be responsiblefor:

  • Contribute to strategyelaboration for Annex 1 remediation in collaboration ProcessInsight Associate Manager and otherdepartments
  • Establish relevant change controlproposals related to the projects with Process Insight AssociateManager and integration of the projects in the Site Project Managerroadmap for each products when applicable.
  • Toensure appropriate documentation and data management usingcorresponding IT system, including QMS softwares (TrackWise,ManGo), ERP (SAP), Discoverant…
  • Assure thetimely delivery of required documents (plans, protocols andreports…) as defined in the project plan
  • Ensurethat all process support activities are carried out at appropriatecompliance levels
  • Participate to theestablishment of raw material control strategy in relation withsuppliers and the MSAT Raw materialspecialist

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 leadingproject, in process improvements and interaction with otherdepartments
  • Sound awareness ofbio-pharmaceutical business
  • Sound awareness ofGMP related issues and Health Authorities'requirements
  • Fluent in French andEnglish

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