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QA IT Specialist

Quality & Laboratory
Cork
Siobhán Lane
Temporary
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Job Reference: JO-2008-65344_1597842230

Summary:


Responsibilities:


* 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.


* Liaising with the global and the pilot site QA IT leads for the project to ensure that the system roll out on site follows the global VMP.


* 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.


* 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.



Responsibilities:


* 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.


* LabX 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.


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Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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