Quality Management Systems Specialist (m/f/d).

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Your Role

  • Maintain the Quality systems strategy and related SOPs
  • Ensure that the relevant procedures are implemented and periodically reviewed, as well as monitor and implement best practices and legislations.
  • Support continuously improve the QMS related to her areas of responsibility and coordinate relevant training activities.
  • Collaborate with the Operational teams to ensure that all the activities meet quality specifications.
  • Participate to and approve the risk assessments related to her areas of responsibility.
  • Support the quality review and approval of Documentation system.
  • Support Health Authorities inspection, internal and/or external audit, and support the evaluation and execution of actions with the Global Response Team (GRT).
  • Ensure the training for other quality systems as a back-up (if applicable) to ensure the flexibility of the overall QMS team

Your Role

  • Maintain the Quality systems strategy and related SOPs
  • Ensure that the relevant procedures are implemented and periodically reviewed, as well as monitor and implement best practices and legislations.
  • Support continuously improve the QMS related to her areas of responsibility and coordinate relevant training activities.
  • Collaborate with the Operational teams to ensure that all the activities meet quality specifications.
  • Participate to and approve the risk assessments related to her areas of responsibility.
  • Support the quality review and approval of Documentation system.
  • Support Health Authorities inspection, internal and/or external audit, and support the evaluation and execution of actions with the Global Response Team (GRT).
  • Ensure the training for other quality systems as a back-up (if applicable) to ensure the flexibility of the overall QMS team

  • qualifiche

    Your Profile

    • Minimum bachelor's degree in a scientific discipline and 2-5 years of experience in a pharmaceutical/biotechnology environment.
    • Experience in establishing or improving QMS systems as an operational SME.
    • Basic knowledge of Health Authority regulations.
    • Experience in the usage of IT systems (CARA, TW, GxP Manager, GLIMS, SAP Lean etc.)
    • Excellent communication skills, flexible team player, curious to learn, and proactive in sharing and collaborating.
    • Analytical and problem-solving abilities, as well as proactive approach to all aspects of quality.
    • Organized and logical in defining workload and delivering project
    • Fluency in English is mandatory; knowledge of French is a plus.

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saremo felici di rispondere alle tue domande in merito a questa posizione.

AL

Andreia Lourenço

  • Randstad Merck Aubonne

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