Spécialiste Assurance Qualité

My client is a growing international biopharmaceutical company with multiple exiting projects on going based in the French part of Switzerland, north of Vaud canton. Due to this current grow, my client is looking for a QA Specialist to support the Quality Assurance activities associated with the start-up of a new green-field large scale API bio-manufacturing facility. This role will support the QA Operations and Quality System Teams to ensure the GMP site readiness and effective Quality oversight of first manufacturing campaigns.

Responsabilities :

  • QA support for implementation of Manufacturing execution System (MES) implementation
  • Review and approve MBRs, specifications and Material Master data
  • Review executed batch records
  • Manage deviations, CAPA and Change controls
  • Support Risks assessments
  • Support the creation and review of operational procedures,
  • Conduct Supplier’s audits
  • Support establishment of Raw materials specification
  • Review and approve Raw Material Master data
  • Release Raw Materials
  • QA oversight of Raw Material analytical method validation
  • Develop and compile quality metrics and Dashboards
  • Conduct periodic trainings on electronic systems
  • Support the Quality Systems initiatives
  • Act within compliance and legal requirements as well as within company guidelines
  • Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees
  • At all times work in a right first time and site readiness approaches for regulatory inspections (Swissmedic and International)

Your Profile :

  • Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing
  • Minimum of 5 years in a Quality Assurance role in a biopharmaceutical manufacturing environment
  • Good knowledge of biotechnology processes and manufacturing
  • Qualified auditor is a plus
  • Demonstrated proficiency in cGMP as well as biopharmaceutical industry regulations.
  • Proficiencies with the quality systems and electronic systems
  • Ability to make pragmatic and compliant decisions
  • Speak, read and write in French and English
  • For more information, feel free to contact : Marine DOLLAT: mdollat@axepta.com

    Marine DOLLAT

    Marine DOLLAT

    Life Sciences Recruitment Specialist

    Noémie OLIVA

    Noémie OLIVA

    Team Leader & Recruitment Management Life Sciences

    Morgane CAYUELA

    Morgane CAYUELA

    Life Sciences Recruitment Specialist

    QA Expert

    Aug 31, 2021QA ExpertCanton of Vaud Permanent Job mdollat@axepta.com Life Sciences

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