QA Manager
ProClinical Recruitment
Basel
vor 3 Tg.

ProClinical is advertising a vacancy for a QA Manager with a pharmaceutical company. The applicant will support this company's Switzerland based team by working with them on their biologic product.

Job Responsibilities :

  • Implementing QMS (Quality Management System) to meet quality specifications / standards and regulatory requirements.
  • Managing all QA / RA staff, whilst also resource planning in QA / RA.
  • Overseeing QMS improvement processes and reporting on the current / ongoing status of the QMS.
  • Working across different departments to communicate quality related activities, and where necessary organising quality training.
  • Using relevant quality tools to improve business performance.
  • Supervising internal Quality Audit programmes and external Audits.
  • Monitoring performance by gathering data and producing statistical reports.
  • Overseeing the Document Change Control process.
  • Skills and Requirements :

  • HND or equivalent in an appropriate scientific or relevant discipline / equivalent experience.
  • Ideally a minimum of 5 years within a medical device manufacturing facility.
  • Excellent organisational skills.
  • Certified Lead / Principal Auditor Experience in QA or Document Management.
  • Experience in an FDA front office inspection environment.
  • A sound understanding of Quality approaches & techniques relating to the Manufacturing Business.
  • Leadership and Communication skills which can be effective at all organisation levels and across national and cultural boundaries.
  • An awareness of the Medical Regulatory obligations relating to Manufacturing.
  • Minimum of 5 years experience in a Quality Management role.
  • Strong communication skills to internal and external audiences.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.
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