Quality Systems & Compliance Manager
Spring Professional Switzerland
vor 22 Std.

We are recruiting, on behalf of our client, an experienced Quality Assurance Manager to establish, design and oversee Quality Systems and Compliance for the Company manufacturing site.

This position is a temporary contract.ResponsibilitiesCompliance : Improve, maintain and assure a continuous improvement of the local Quality Systems to assure the compliance to current pharmaceutical GMP’s (Europe and USA) and company corporate GuidelinesFollow up on Corporate Guidelines implementationCoordinate a continuous inspection readiness programManage the Supplier Qualification Assurance (QAA, risk assessment) and supplier deviationsApprove packaging and QC specifications Assure the compliance of the site to regulation : QA review for issuance of GMP documents (SOP’s protocols, reports.

  • Main contact for RA requestsIn absence of Responsible Person : communication to SwissMedic and compliance to applicable RegulationsAuditingManage internal and external audits.
  • Lead auditor in self-inspections and external audits.Quality SystemsManage CAPAs (workflow, meetings with the concerned functions, KPIs)Manage change controlLead the Documentation and training systems;
  • Expresso and Success Factor business owner.Coordinate and prepare Annual Product Reviews with the objective of verifying the consistency of the processPropose a training program and assure a follow up.

    Organize GMP training for the siteManage and Lead the risk analysisPerform audit trail review of GMP systemsMonitoring and CommunicationEstablishes Compilations, trending of GMP data and Key Performance Indicators (KPI)Diligently report to head of Quality Unit any Quality Alert / issue and actively participate to resolve significant Quality issues when they ariseAssure a communication flow and collaboration with Operations and other functions to assure a product life-cycle qualityBackupBackup for quality documentation management and issuance of batch recordBackup for compliance approval of QC lab documentation (SOP, specifications, revision analytical dossier QCA & QCM, Analytical method validation documents, stability documents, LIMS modification)Backup in due date extension for CAPA and Change controlProfileTechnical Degree from a University, Engineering School or equivalent in Life Sciences, (e.

    g. Pharmacy, Chemistry, engineering or related fields)At least 4 years in quality operation management in pharmaceutical industryExperience with Deviations and CAPA management system (eg : Trackwise), Documentation Management system, and SAPFluency in English and French is required for the roleContactSpring Professional Life Science : +41 58 233 40 20#boostVous pouvez postuler en ligne en cliquant directement sur le button "Postuler"Nous découvrir Booster votre carrière, décrocher un emploi qui vous motive ou trouver une nouvelle opportunité pour vous épanouir dans votre vie professionnelle.

    Autant d’objectifs auxquels nous croyons et pour lesquels nous vous conseillons jour après jour. Spring Professional est une entreprise de The Adecco Group, spécialisée dans le placement fixe et temporaire de professionnels qualifiés.

    Découvrez ce que nous pouvons faire pour vous. Postulez à ce poste ou à l’un des plus de 500 autres postes sur SpringProfessional.chJN -072020-300191

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