Need CSV services in East Hanover, NJ
Technical Skills:
· In depth (administrator level preferred) knowledge of Microsoft windows operating systems.
· Adept with Microsoft Server (Group Policy and Active Directory)
o Will be leveraged on the backend for CS staging, standardizing, centralizing management, and documenting within the configuration specification and qualification protocol as required.
· Develop CS Configuration Specifications adhering to 21CFR Part11 requirements
· Deviation Support
o Root Cause Analysis
Documentation and Technical Writing Skills:
· Authored/Developed Protocol Qualifications, URS, Summary Report, Deviations, etc.
Qualification Experience:
· Executed CSV Qualification Protocols
· Adheres to GDP (good documentation practices)
Soft Skills:
· Engage with other team members to develop documentation as needed.
· Able to leverage existing documentation from multiple sources and produce applicable required documentation.
· Understand 21CFR Part11 requirements and assist with efficiency and configuration based on best practices.
· Work with end users/operators, and system owners to develop URS as required.
