Quality Associate (GMP Compliance) (temporary contract 9 months)
SOPHiA GENETICS
Geneva, Geneva, Switzerland
vor 5 Tg.

Description

Would you like to be part of a dynamic and exciting team delivering high level performance that has a direct impact on the lives of cancer and rare disease patients worldwide?

Join our growing team and use your exceptional technical and organisational skills to help us deliver on our mission of democratising Data-Driven Medicine.

Our products are used by over a thousand healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.

Be part of our mission to disrupt the healthcare and democratise the data driven medicine! SOPHiA is looking for a Quality Associate to join the Quality team in our Lab in Geneva.

This contract has a duration of 9 months due to maternity leave.

Your main tasks will be :

  • Ensuring the company’s Quality Management System is kept up to date at all time.
  • Ensuring operating procedures are appropriately documented and comply with ISO13485 : 2016.
  • Monitor, review, update and document relevant processes such as Product Development Lifecycle Management Process, Software Lifecycle Management Process, Document Control, Internal Audits, CAPA, Management Review, Complaint Management, Change Control, etc.
  • Work with internal stakeholders to ensure that quality objectives are met and processes are adequately structured, executed and documented.
  • Writing, maintaining and updating quality documents (SOP’s, forms, Work Instructions).
  • Performing routine inspections on quality documentation and quality tests.
  • Participating to or leading internal and supplier audits.
  • Keep track of the audit agenda making sure that deadlines are met, trainings have been done and projects are not delayed.
  • Requirements

  • Bachelor’s degree (preferably Quality, Biology or another scientific field)
  • 2 - 5 years of experience in Quality Assurance in a biotech laboratory (preferably in production)
  • Strong knowledge of ISO 13485 and ISO 14971.
  • Strong knowledge of GxP requirements
  • Proficiency in English both written and oral
  • Benefits

  • Career opportunities in a fast-growing company with worldwide reputation
  • A flexible and friendly working environment with a collaborative atmosphere
  • Fantastic office locations in Switzerland.
  • An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
  • A fast-growing company with plenty of opportunity for personal growth and development
  • Start : ASAP (or as agreed)

    Contract type : full-time, temporary (9 months)

    Application process

    If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.

    After an initial screening process, candidates will be invited for remote interviews. Selected candidates will then be invited for personal interviews.

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