Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports. Prepare Change Control documentation. Execute test scripts. Perform risk assessments. Must know 21 CFR Part 11. Consult on Projects. Prepare Project Plans. BS in a technical field and 7-10 years’ experience in GxP environment.
Provide Leadership to the Validation effort (make sure the right things are being done)
Manage the preparation and approval of (make sure the things being done a done correctly)
Validation documentation deliverables
Migration documentation deliverables.
Create the content of the validation deliverables
Tracking and archiving all documentation deliverables
Manage the negotiations of deliverables with CQA
1) Extensive Pharmaceutical Experience.
2) 7-10 years’ experience in IT Quality Validation in GxP environment. Will consider less experience.
3) Experience in protocols including IQs/OQs/PQs, project summary report.
3) Deep understanding of SDLC and IT/system change management processes.
4) Experienced in writing system implementation project related documentation such as project charter, implementation plan, communication plan, risk management plan.
5) BS degree required. Advanced degree preferred
6) Technical writing experience is a must.
Suppliers: Candidate will be supporting validation for software hosted internally and externally. Candidate must be familiar with hardware qualification. Most of the projects are upgrades to systems – some small and some large. This candidate must be engaged in the projects and understand how to review proposals, plans and be able to come up with solutions, ideas. Should be an “”out of the box”” thinker and take initiative.
Source: Job Diva – Job Listing