13483 – QA IT Specialist – Carlow Contractor

Purpose:

The successful candidate will join the QA IT team to provide independent oversight and support for the computerised systems being implemented and modified as part of the site expansion project to 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.

Responsibilities:

• 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.
• Where required, engaging with QA IT teams from other sites to standardise and align approach to computerised systems compliance.

Minimum Qualifications and Experience:

• 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 and PAS-X experience will be an advantage.