Description
A Pharmaceutical company based in the South - West is currently seeking the services of a Project Manager/Computer Systems Validation Lead to provide support to their Electronic Quality Management System (EQMS) Implementation Project for a 12 Month contract.This position will require the ideal Computer Systems Validation Lead to work on site for 2 - 3 days per week.
Scope includes, but is not limited to:-
* Liaison with Key Stake Holders / User departments (QA, Validation, IT, Vendor (MasterControl®), System Owner and senior management team.
* Manage project schedules including key mile-stones.
* Report and liaise with project team to resolve issues.
* Provide highlight reports to senior management team/project board.
* Review key validation deliverables.
* Generation of Validation Protocols, Test Scripts and Reports.
* Finalise Validation Summary Reports.
The ideal candidate MUST have knowledge of:-
- GAMP4/5 Life-Cycle
- FDA 21 CFR Part 11
- Proven track record of project management of complex IT projects.
- Familiar with Electronic Quality Management Systems, specifically MasterControl®
(or similar).
- Experienced in the data migration elements of implementing an EQMS system (Document migration, including meta data etc.)
- Familiar with a 'Risk-Based' approach to validation.
They will also consider candidate's who have experience of working with Track wise systems and LIMS systems.
To learn more about this opportunity. Please send in your current CV to Reshma Patel to or alternatively contact Reshma Patel directly on .