Job Description
The QA Analyst will report to the QA Manager and will assist in ensuring that company operations and operating procedures are in compliance with all appropriate cGMP regulations and guidelines. Will provide ongoing supervision of compliant subsystems of the site Quality Management System. Contribute to Quality processes/initiatives at a local and global level as required.
Responsibilities:
Review of Batch Record Documentation
Compilation, Review and Approval of cGMP Documentation
Perform QA inspection of production equipment and facilities for commercial and clinical supply.
Perform internal cGMP walk-downs and Audits of multiple operations
Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required offering a quality perspective on any deviations.
Support on-site inspections by all external regulatory bodies
Conduct on-site cGMP training, Induction and Refresher, provide input into training topics based on site experience
Conduct training of QA technologists, where appropriate
The QA Analyst is expected to report any deviations to the QA Manager/Quality Director upon noting an occurrence - to be the point of contact for production/maintenance/logistics and quality departments and to follow through on any quality concerns with these areas
To assume responsibility for SAP PM.
Candidate Profile:
The QA Analyst will have a B.Sc in Science and at least 2 years relevant
pharmaceutical experience, including at least 1 years QA experience
For further information on this QA Analyst position please contact Gavin Kennedy at The RFT Group on 01 2302400 / gavin@rftgroup.ie Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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