Post Market Surveillance & QA Complaints Specialist

Posted 13 January 2022
SalaryNégociable
LocationFribourg
Job type Permanent
DisciplineLife Sciences
ReferenceBBBH506573_1642070677

Job description


For its Life Sciences partner, Kelly Life Sciences is looking for a:
Post-Market Surveillance & QA Complaint Specialist
(Permanent position)

Your mission:

  • You will be responsible to perform and follow up post market surveillance (PMS) activities,
  • You will provide leadership to apply and continuously improve the system in accordance with the Global QA
    strategy and in compliance with European and FDA requirements.



Your responsibilities:

  • You support the PMS activities and complaints handling process and have the QA oversight of the product customer complaint management activities.
  • You lead the preparation of PMS plan and report, ensure timely analysis of the data.
  • You support the products support staff in managing and resolving complex complaints and initiate product quality actions (Hold, Field Action, Field Safety Notice) when needed.
  • You develop and track meaningful metrics to monitor process effectiveness and communicate results and product trends to internal stakeholders.
  • You provide leadership to continuously improve the Quality System in accordance with the Global QA strategy and in compliance with European and FDA requirements.
  • You participate to authority, notified body and customer audits. You participate to the internal audit program as Internal Auditor and to external audits as Quality Expert, especially for complaints system.
  • You support, when necessary, Quality Management System activities and projects as Quality referent for deviations, change control and CAPA or
    Project lead.



Your Profile:

  • Master's degree in biology, biotechnology or similar field.
  • 3 to 5 years' experience in post-market surveillance and/or complaint handling
  • Strong knowledge and understanding of regulatory agency cGMP/ISO requirements, as well as requirements for Post market Surveillance activities.
  • A good knowledge of Immunology or hematology would be an advantage
  • Strong ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions.
  • Fluent in French and English (spoken and written)



Your contact at Kelly:
Mrs Karine Legerot
Senior Consultant Professional Staffing Life Science
Kelly Life Sciences Geneva