Connecting...

QA CMO Associate

Job description

QA CMO Associate

This global biopharmaceutical company is looking for a driven individual to join their Quality team in Cork.

The Quality Assurance Associate is responsible for supporting quality systems, assisting with the batch release process and pack label finished goods orders produced by external Contract Manufacturing Organisations

Job responsibilities:

  • Assistance with oversight of the supply chain, manufacture and packaging of products in various CMO’s
  • Review Manufacturing / Packaging batch records and Quality Control documentation prior to final batch release
  • Review and approval of SOP’s, master batch records and product specification
  • Provide Quality oversight of deviation and investigation reports to ensure root causes identified and solved
  • Assist with audits and requires of CMO to ensure compliance with cGMP
  • Assist with regulatory requests and inspections

The successful candidate will have:

  • BSc degree in technical discipline
  • Minimum 3 years’ experience in a cGMP regulated FBDS, drug product manufacturing and or packaging environment is a pre-requisite for application
  • Experience with participation in regulatory inspection of defending departmental functions in audits or regulatory inspections
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines and expectations

If you would like to discuss this role, or any other role,  reach out to Louise Whitty on 021 2359140 / lwhity@sigmar.ie 

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.