The ideal candidate will need to understand Electronic Document Management System workflows including CSV methodologies. Resource is needed to supplement IT CSV validation review workload including plans, specifications, designs, protocols, test scripts, reports and operational procedures.
· Knowledge of SDLC
· Knowledge of Electronic Document Management System (Specifically Documentum)
· SME Review and approval of CSV validation documentation
· Provide advice, guidance, coaching and mentoring to client for proper validation of computer systems
· Expert knowledge of GMP, 21 CFR part 11, 21 CFR Parts 210, 211
· Good documentation practices
· Long-term experience in pharmaceutical manufacturing in technical or QA capacity
· Regular and effective communication of project status to Project Management.
Experience with Electronic Document Management Systems preferred but candidate should be well-rounded enough to be able to transfer over to other CSV validation efforts at conclusion of project.