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QC Manager

Job description

QC MANAGER - Quality Control

This is a West Dublin based permanent job in a global, rapidly expanding pharmaceutical company. Excellent salary and benefits.

This is a very exciting opportunity to be involved in a start up lab and manage a very busy and growing QC lab function.

JOB RESPONSIBILITIES:

  • Responsible for the overall management of three separate Quality Control labs supporting the manufacture of API, finished capsule product and biologics
  • Ensure that QC laboratories are set up and operate in compliance with GMP/GLP   
  • Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing
  • Lead and participate in the Technical Transfer / Validation of new and existing processes
  • Manage the investigation into any non-conformances
  • Generate, implement and control of QC annual budget
  • As required, act as designee for the Site Quality Head in their absence
  • Participate as required in global project teams relating to QC and wider quality activities

 

JOB REQUIREMENTS: 

  • Degree in Science or other relevant field
  • More than 10 years’ experience in the pharmaceutical industry and minimum of 3 years QC Laboratory Management experience
  • Experience in method validation/development and tech transfer an absolute must
  • Experience in budgetary control and audit preparation
  • Thorough knowledge of GMP and current FDA & EMEA regulations for API and OSD pharmaceuticals
  • Previous experience in managing the performance of individual team members and that of the overall team
  • Knowledge and experience of Lean Laboratories is preferable
  • Previous experience in setting up a new QC laboratory is desirable

If you wish to apply to this job send your CV to chenry@sigmar.ie or contact Clara Henry on 01 4744676 for a confidential discussion.