Provide validation experience and guidance during equipment design, software design, build, debug, and qualification phases of a project.
Write overall project quality (validation scope) plans. Organize, guide, and write requirement specifications as necessary.
Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies. Interface with internal and client validation and engineering teams to secure document approvals.
Oversee and execute validation qualifications at our facility and at the customer's site.
Organize, guide, and write qualification plans and protocols as necessary.
Work through validation documentation in a timely manner to meet project schedules.