QA IT Specialist
QA IT Specialist required for a large Pharmaceutical company in the area of Northumberland. 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. The QA IT specialist will support routine and project CSV activities, including upgrades of existing process control and laboratory systems
Responsibilities of the QA IT Specialist:
* 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 deviations.
* Ensuring consistent approach to qualification, change and deviation management across systems and projects.
* Managing and prioritising dayto-day activities through active alignment with the assigned projects and business areas, and supporting other areas as needed.
* Providing timely and proactive 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
On offer for the successful candidate:
* Opportunity to join a globally leading Pharmaceutical company
* An initial 11 month contract
* Pay rate between £20.00/hour £50.00/hour depending on the level of experience
Experience required to be the successful QA IT Specialist:
* Min. 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.
* PCS and PASX experience will be an advantage.
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