Experienced QA Specialist required for our multinational client based in Shannon. This is a permanent full time position offering an excellent salary & benefits package.
JOB PURPOSE:
To act as Quality Assurance representative to ensure that the plant is operating to cGMP requirements and that processing is in compliance with regulatory filings. To liaise with the all site functions as necessary to resolve quality issues and perform batch review to permit product release.
PRINCIPAL ACCOUNTABILITIES:
1. Quality Management System (QMS)
• Deviation Management system
Supervise and manage the site Deviation Management system to ensure timely and accurate recording of deviations and subsequently that an appropriate level of investigation is performed and documented to permit resolution and closure of deviations ahead of batch release.
• Compliance actions (CAPA, preventive actions, audit actions)
Assure the suitability of assigned compliance actions and associated closure timelines before approval and formal entry into site systems. Monitor and drive closure rates of compliance actions for QAV and those functional areas supported as necessary to assure the overall site compliance profile is maintained.
• Change Control
Support the Change Control process by assisting in the evaluation of changes ahead of approval, reviewing change controls post implementation and assessing completion of assigned actions to permit closure.
• Product Quality Review
Participate in the scheduling and tracking of PQR reports required and ensure that all PQR reports are prepared on schedule and in line with site standards.
• Audits and Inspections
Participate in regulatory inspections, corporate and customer quality audits as necessary. Perform internal audits and external audits of suppliers as appropriate to provide necessary assurance in cGMP standards.
• Quality Council
Actively present and participate in Quality Council meetings to drive quality awareness at the site and ensure management review of the QMS is achieved.
Actively trend and monitor established KPI’s at site level and ensure that support systems (e.g. Quickscore) are maintained.
2. Site Support
• Review manufacturing records for completeness and cGMP compliance to support the release process as necessary.
• Review and approve plant manufacturing instructions to ensure conformity with site standards and regulatory processes
• Evaluate site procedures on an on-going basis to ensure compliance. Review and approve procedures in Mikado system as necessary. Prepare SOP updates as requested by quality management ensuring where appropriate that UCB global approach is reflected.
• Provide training, support and advice to colleagues on-site to facilitate cGMP improvement and best practice.
• Participate in global initiatives and share knowledge both internally and externally to raise standards to meet industry best practices.
• Interact with other functions on site, particularly Operations, Supply Chain, Engineering, QC and Technical Services to ensure that QAV and site goals are achieved
• Participate in site initiatives such as CI projects in order to promote improvement activities and achieve goals and to further personal development.
3. Validation, Qualification and Projects
• Support process, cleaning and analytical validations and equipment qualification programmes on plant as appropriate.
• R
