"IT Compliance Lead"The Planet Group • Richmond, VA, United States
"IT Compliance Lead"
The Planet Group • Richmond, VA, United States
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Experience
- At least 7 years’ experience in pharmaceutical business processes with in-house and outsourced manufacturing and the associated IT solutions.
- At least 7 years’ experience dealing with pharmaceutical industry regulations and guidelines (including FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP)
- 7+ years’ experience in a Computer Systems Validation role, with at least 3 years in a leadership role
- Experience in GxP inspections performed by regulating authorities
- Strong track record of contributing to projects and achieving results within a validated regulatory environment
- Experience working with IT validation document repository (ValGenesis), electronic signature solutions (Adobe and DocuSign), IT control management system (AuditBoard) and corporate quality management system (TrackWise and Veeva).
- A working knowledge of IT application development, implementation and support processes within a regulatory environment
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Compliance Lead • Richmond, VA, United States
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