- A new opportunity has arisen for a QA IT Specialist Shopfloor Systems to join our client’s busy pharmaceutical site in Co. Meath.
- The successful candidate will join the QA IT team on a site expansion project to provide independent compliance oversight and support for the implementation of new shopfloor automation systems and modifications to existing site systems.
- The QA IT specialist will ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements.
- The QA IT specialist will support a number of shopfloor system, including DeltaV, PLC/SCADA systems, OSI PI and MES.
- Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for new and modified systems.
- Providing independent quality review and approval of system changes.
- Supporting and approving computerised systems investigations and test deviations.
- Ensuring consistent approach to qualification, change and deviation management across systems being implemented on the project.
- Providing timely and pro-active QA IT support and guidance to facilitate project timelines, including close collaboration with the technical and business units.
- Where required, engaging with QA IT teams from other sites and capital projects to standardise and align approach to computerised systems compliance.
Education & Qualifications Required:
- Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
- Working knowledge of relevant regulations and industry standards.
- Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
- Excellent communication skills.
- Project management experience will be an advantage.
- DeltaV, PLC/SCADA, OSI PI experience and/or PAS-X experience is essential.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.