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Quality Assurance Officer

  • Location: County Westmeath, Leinster, Ireland
  • Job Type:Permanent

Great new perm role for an experienced Quality Compliance Officer with a growing pharma organisation in Athlone. Co. Westmeath

Quality Assurance Officer responsibilities:

  • Quality Assurance responsibility for document change control, complaints & CAPA management within the organization

  • Maintain Quality Management System processes in line company procedures

  • Monitor investigation timelines for quality issues e.g. non-conformance and Issuance and archiving of quality documentation 

  • Report out key process indicators (Document Change Control, Complaints & CAPA) 

  • Support preparations for internal and external audits 

  • Aid in the investigation and evaluation of audit findings

  • Ensure root causes are appropriately identified and corrective actions are verified for effectiveness

  • Support vendor qualification activities where appropriate

  • Review records and documents for completeness and compliance with GMP/GDP requirements and internal organizational procedures

  • Participate in interdepartmental initiatives for continuous improvement of procedures, processes and systems and maintain a list of compliance initiatives

  • Take on any further reasonable responsibilities as assigned to you by your manager

Quality Assurance Officer requirements:

  • Bachelor's degree in any Life Science, Biomedical, or related field (or equivalent work experience)

  • Minimum of 2 years relevant experience. within the pharmaceutical sector

  • Good understanding of cGMP, 21 CFR Part 211, and related regulations associated with pharmaceutical product control

FULL SPEC ON APPLICATION**

For a confidential discussion and more information on the role, please contact Tina Egan.

tina.egan@collinsmcnicholas.ie