· 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.
· 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.
· PLC/SCADA, OSI PI and PAS-X 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
'Not Just Placers.........Partners'
The Life Science Specialists