This is an 11 month contract with a view to extension
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 laboratory 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 new analytical instruments and implementation of a new data acquisition system.
• 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.
• Min. 5 years of experience in QA IT/CSV, CSV, lab instrumentation 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.
• Analytical systems experience is essential.
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