QC Specialist (m/f/d).

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job details

summary.

  • specialism
    industry
  • contact
    Laurène Soumahin
  • reference number
    129085-40177

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job details

Take the opportunity to be a key protagonist in Quality Control (QC) for Biopharmaceuticals on a growing site in a mutating environment. By joining us you will be part of a site which delivers outstanding solutions to patients for more than 30 years. Contribute to this exciting and challenging journey within the QC Support and Technology team by supporting crucial activities related to the QC laboratory new equipment implementation.

Your role :

  • In link with the leader on this activity and by close collaboration with technical services and quality assurance you will support :
    • the needs and prerequisites for successful and efficient IQ/OQ/PQ of new QC lab equipment as well as the related compliance and troubleshooting.
    • write PQ protocol, execute PQ and write PQ repot
  • Your role focusses on completing the implementation of new equipment associated with our ongoing and planned equipment related projects such as LAL analyzer, electrophoresis capillary, UPLC and UV spectrophotometer.
  • You shall be rigorous, open minded and source of solution to allow efficient collaboration between services and to ease meeting milestones and delivering projects in the planned schedule.
  • You ensure also full respect of GMP's, Data Integrity, Policies and SOP's in daily activities and participates in maintaining the quality system within QC.

Take the opportunity to be a key protagonist in Quality Control (QC) for Biopharmaceuticals on a growing site in a mutating environment. By joining us you will be part of a site which delivers outstanding solutions to patients for more than 30 years. Contribute to this exciting and challenging journey within the QC Support and Technology team by supporting crucial activities related to the QC laboratory new equipment implementation.

Your role :

  • In link with the leader on this activity and by close collaboration with technical services and quality assurance you will support :
    • the needs and prerequisites for successful and efficient IQ/OQ/PQ of new QC lab equipment as well as the related compliance and troubleshooting.
    • write PQ protocol, execute PQ and write PQ repot
  • Your role focusses on completing the implementation of new equipment associated with our ongoing and planned equipment related projects such as LAL analyzer, electrophoresis capillary, UPLC and UV spectrophotometer.
  • You shall be rigorous, open minded and source of solution to allow efficient collaboration between services and to ease meeting milestones and delivering projects in the planned schedule.
  • You ensure also full respect of GMP's, Data Integrity, Policies and SOP's in daily activities and participates in maintaining the quality system within QC.

  • qualifications

    Who you are

    • Graduated in Life Sciences or Metrology (Bachelor or Master)
    • Previous experience (/2years) in GMP environment
    • Previous experience in QC laboratory
    • Ability to interact with diverse interlocutors/customers (e.g. technical services, quality assurance, project managers, etc.)
    • Collaborative, resilient and source of solutions
    • Awareness of Data Integrity and Data Management
    • Fluent in French and English

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LS

Laurène Soumahin

  • Randstad Merck Aubonne

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