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Validation Manager (IVD - Medical Device)


  • A hirdetés 936 napja lejárt

For one of our partners, a biotechnology company based in the French part of Switzerland, Kelly Scientific is looking for a Validation Manager.

Your mission
• Define and set strategies for all validation and qualification activities (equipment, utilities and facilities and processes) associated with the introduction of products through design / development, technical transfer, manufacturing and licensure
• Master validation plan ensuring success at each phases of product development

Your tasks
• Ensure validation issues are communicated effectively and managed
• Act as the primary interface between the Validation Department, Assay / Product Development team and all manufacturing partners
• Ensure prompt and timely approval of validation records and management of all allocated quality management system records i.e. non-conformances and change controls
• Identify, define and document product and process requirements including critical to quality factors / attributes and critical process parameters
• Prepare robust validation documentation to provide a high level of confidence through documented evidence of the ability of items under validation to perform consistently and reliably delivering all identified critical to quality factors / attributes at critical process parameters
• Ensure preparation of identified regulatory submissions to achieve necessary licensure / marketing authorizations
• Participate in internal and external audits (regulatory and client)

Your profile
• Degree in science or quality
• Minimum 3 years validation experience in regulated environment
• Experience in IVD or Medical device company
• Team management ability
• Experience with Six Sigma / Lean Manufacturing, Statistical Analysis and Computerised Systems Validation
• Knowledge and experience in GMP/GLP environment and regulatory requirements
• Excellent communication, presentation and reporting skills
• Fluency in English
If you are interested please send your resume to

Region: Vaud
Vertragsart: Dauerhaft
Kategorie: Qualitätswesen
Veröffentlicht am: 09.10.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1410-16600
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
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