QA Specialist

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
  • 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 : Noémie OLIVA: noliva@axepta.com

Noémie OLIVA

Noémie OLIVA

Team Leader & Recruitment Management Life Sciences

Morgane CAYUELA

Morgane CAYUELA

Recruitment Specialist Life Sciences

Marine DOLLAT

Marine DOLLAT

Recruitment Specialist Life Sciences

QA Specialist

May 27, 2021QA SpecialistNeuchâtel Permanent Job noliva@axepta.com Life Sciences

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