The successful candidate will join the site QA IT team to provide independent oversight and support for the site computerised systems to ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements.
- Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports.
- 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.
- Providing timely and pro-active QA IT support and guidance to facilitate project timelines.
- Liaising with the Data Integrity Champion to ensure compliance with the regulatory and company DI expectations.
- Where required, engaging with QA IT specialists from other sites, central validation groups and other internal organisations to ensure consistent application of SDLC and DI standards and procedures.
- Experience in QA IT/CSV, CSV, laboratory systems engineering and/or a similar role in the pharmaceutical industry.
- Working knowledge of relevant regulations and industry standards, including current data integrity expectations and best practices.
- Experience with a wide range of laboratory systems.
- Proven ability to meet timelines, prioritize tasks and engage with stakeholders.
- Excellent communication skills.
- Project management experience will be an advantage.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
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The Life Science Specialists