Position: Mid-Senior level

Job type: Full-time

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Job content

JobdescriptionDo you have several years of operational experience in advanced analytical? Do you have knowledge of GMP? Then you should read the following lines!One of our clients, an international healthcare company, is looking for a:QC Validation & Compliance ManagerContact type: permanentLocation: Vaud Cantonto provide analytical expertise for validation, transfer, periodic review and remediation as well as support to other QC teams (Raw Material, Finish Product) to investigate analytical issues and integrate new projects (NPI, New Method, Sourcing)Your tasksAnalytical activities
  • Manage the validation activities of the QC analytical testing laboratory and owns the analysis resulted from Site Validation Master Plan process for QC Plant.
  • Manage new/updated analytical method introduction at our client plant ad transfer analytical methods from one site to the other
  • Provide strategy for internal analytical validation and remediation issues in collaboration with AS&T. Support all QC sub functions in problem-solving and complex projects
  • Manage the QC Validation Scientists providing accurate analytical data recorded according to Testing Monographs, SOPs and Regulatory Dossiers
Quality System
  • Acts as Senior Expert in Quality systems in laboratories implementation in accordance to QMS and GMPs, review for unplanned deviations, change controls, corrective and preventive actions.
  • Manage the Compliance Specialists of the QC analytical testing laboratory to agreed GMP requirements, standard following and specifications
  • Respect all GMP standards to support the requirements expected by Swissmedic, European Union agencies and other regulatory bodies.
Interactions
  • Represent the QC department for regulatory question, analytical validation/transfer, analytical remediation and ensure strong relationship with operations,
  • Manage and provide timeline, resources, and cost of the Site projects.
  • Drives continuous improvement initiatives which positively impact cycle time, productivity, efficiency, and quality of work.
  • Work closely with the QC PF Manager.
Your Profile
  • Min. 5-10 years in the pharmaceutical industry with operational experience in advanced analytical
  • A first experience in team management
  • Global process understanding (production, laboratory, support services, regulatory,…)
  • French (Fluent) & English (read, written and understood)
  • SAP/LIMS/Empower software knowledge
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Deadline: 05-05-2024

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