send resumes to ke...@keeninfotek.com
This is 6 weeks in boston, rate is open- must have pharma experience.
*need a GxP Validation Writer/Tech Writer to document the project to meet
- This individual needs to be able to produce define phase SDLC and GxP
artifacts including validation master plan.
- Produce design, test, and deploy phase SDLC and GxP artifacts
identified in the define phase most likely including detailed design
specification (most content provided by client desktop technology lead),
test plan and report, test cases and scripts, traceability matrix,
production monitoring plan and report, training plan, production
installation report, validation summary report
- Works closely with clients’s CSQA to align the needs of the project
with company’s GxP compliance needs.
- Prior pharmaceutical/FDA experience required.
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