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von: Kelly Services Switzerland | localité: GenevaN: KellyServicesSwitzerland
Pour notre partenaire base à Genève, nous sommes à la recherche d'un :
Senior Manager, QA (Durée de 6 mois)
Job Responsibilities:
– Provide overall direction to the Quality Specialist by supporting master and executed lot record reviews/approvals for commercial programs, shop floor QA supervision and deviation/CPA system.
– Ensure departmental and corporate employees comply with required procedures.
– Manage a team of QA specialists.
– Develop and/or support training material for quality systems, including deviation/APC system and batch record review.
– Ensure training and certification of QA personnel.
– Work as a team to ensure batch, deviation and CAPA registration deadlines are met for batch release.
– Act as quality system manager for deviations and CAPAs.
– Support manufacturing change controls as QA subject matter expert, performing additional impact assessments and QA approvals as required.
– Track, trend analyze, compile and report on customer-specific and internal quality metrics as required.
– Attend operational meetings to support manufacturing operations and lot disposition activities.
– Participate in customer audits
Profile:
– Bachelor's degree
– Minimum 3 years' experience in a similar position in the medical devices field
– Very good knowledge of standard IT tools (SAP an asset)
– French mother tongue with excellent knowledge of English (C1 minimum)
– Experience in project management and change management (packaging change, change control, documentation and planning).
