QA Systems Document Control Lead

Document Control Lead required for the QA Systems department at a global Biotech Manufacturing Facility in Dublin. 

Ireland is a hive of activity for the Life Sciences industry at present with global players investing heavily here in new facilities. 

An excellent long term contract opportunity has arisen at a state-of-the-art manufacturing facility in Dublin for a QA Systems document Control lead to join the team. 

This role will be working 40 hours per week, 5 days per week and due to the current COVID-19 travel restrictions, we are just accepting applicants from within Ireland at this time. 

The ideal candidate will have the following expereince:

• 5+ years’ experience in a cGMP environment preferably within a Quality Management role within biopharma
• Direct experience of GMP documentation management within a pharma/biopharma/medical device company including exposure to regulatory agencies or other authorities of similar standing
• Experience delivering GxP documentation to support manufacturing operations and packaging activities
• Responsible for driving Right First Time and Continuous Improvement across the documentation systems network including initiating quality improvement plans and leading resolution of remediation activities from CI or inspections
• Management and coordination of the archival process including on-site and off-site archival and retrieval (when / where)
• GxP Logbook Management including issuance and reconciliation (when / where)
• Provide quality documentation support, oversight and guidance for deviations and investigations and ensure robust root cause analysis/CAPA and timely closure (when / where)

For more information on this opportunity, please apply with a copy of your up to date CV today! 

The candidate must have the rights to work in the location stated in the job advert.

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