Job Reference: J5632704
Updated On: 14/02/2020
Status: Now Interviewing
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We are currently looking for a IT Systems Project Manager to join a leading Cell and Gene Therapy company based in the Hertfordshire area. As the IT Systems Project Manager you will be responsible for delivering new IT systems in a GMP compliant environment.
Key Duties and ResponsibilitiesYour duties as the IT Systems Project Manager will be varied however the key duties and responsibilities are as follows:
1. You will be introducing a range of new IT systems into the business including a eQMS (electronic quality management system), LIMS (laboratory information management system), WMS (warehouse management system)
2. You will need to ensure that all IT applications are compliant to pharmaceutical regulations such as GAMP5, 21 CFR part 11 and Eudralex Vol 4 Annex 11. Including computer system validation.
3. You will work alongside the Head of IT to ensure that all IT projects are delivered to budget and on time to Prince 2 or similar Project Management framework
4. You will need to review, evaluate and mitigate potential risks in respect to the projects, as well as maintain Risk Management system and risks for both systems.
To be successful in your application to this exciting opportunity as the IT Systems Project Manager we are looking to identify the following on your profile and past history:
1. You will need to have held a Project Manager role or similar in a pharmaceutical or biotech organisation and have worked on similar projects
2. You will need to have GAMP 5 & Annex 11 understanding and experience, and also be familiar with the MHRA requirements concerning validated systems data integrity.
3. Have a Prince 2 project certification or equivalent
Key Words: Project Manager, IT, IT Systems, GAMP5, 21 CFR, Pharma, Biotech, LIMS, eQMS, WMS, CSV, Data
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