send resumes to

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
FDA requirements.*

   - 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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