QA IT / CSV
PE Global is currently recruiting for a QA IT / CSV Engineer on behalf of our client based in Cork. This is an initial 12 month contract role.
The successful candidate will join the site QA IT team to provide independent oversight and support for the existing and new computerised systems on a major capital project. The QA IT specialist will ensure that the relevant computerised systems are compliant with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. Systems in scope will include process control systems, BMS, historian and MES.
- Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, test protocols and reports for new and modified systems.
- Providing independent quality review and approval of system changes.
- Supporting and approving computerised systems investigations and deviations.
- Ensuring consistent approach to qualification, change and deviation management across systems and projects.
- Managing and prioritising day-to-day activities through active alignment with the project team, and supporting other areas as needed.
- 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.
- 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
- Expert 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.
- PLC/SCADA, OSI PI and PAS-X experience will be an advantage.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to email@example.com