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Libby O'Donoghue
Life Science

+353 1 507 9254
[email protected]
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Details

Senior Quality Assurance Manager


Reference:LO A008112 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Manager

Senior Quality Assurance Manager
Our client, a global pharma organisation based in Dublin are currently recruiting for a Senior Quality Assurance Manager to join their team on a permanent basis.

Responsibilities

  • Support, review and develop GMP systems on site and administer the change control systems in accordance with the relevant SOPs
  • Administer and co-ordinate the deviation reporting system in accordance with the relevant SOPs
  • Review monthly reports for the management system and ensure corrective actions are implemented as appropriate
  • Manage regulatory and customer inspections associated with Company business
  • Review investigate and closeout of product complaints as per the product complaint SOP
  • Overall responsibility for the on hold and reject system
  • Ensure that manufacturing license for the site is updated as appropriate and ensure all batches are reviewed effectively before product release
  • Ensure adequate reference samples and appropriate records are archived for all products shipped
  • Manage the preparation of annual product review reports as per the relevant SOP
  • Maintain and co-ordinate the approved supplier qualification program
  • Publish and maintain the internal audit schedule. To execute this calendar of events including reporting and close out of all issues

Requirements

  • 3rd level qualification in BSc required, MSc desirable
  • Minimum of 5 years GMP/Pharmaceuticals experience
  • QP qualified desirable but not critical
  • Strong people management skills and experience