Systems Administrator (GMP, CFR Part 11)
Baltimore, MD, USA
*This role is on-site 2-3 days/week in Baltimore.
*Relocation assistance provided!
The Denzel Group, an award-winning search firm, has been chosen to work with a Global Pharma leader in Baltimore on their quest for a talented GMP Data Integrity Systems Analyst. In this role, you will ensure GMP and CFR Part 11 compliance and data integrity of computerized systems.
Identify computerized needs for new systems, upgrades, and decommissioning.
Coordinate and create data flow process models and system configuration documents.
Author documentation such as procedures, summary reports, and status reports related to the data integrity projects.
Project Management of data integrity activities.
Supports risk assessments.
Function as system administrator for computerized systems.
4+ years’ experience with data integrity and computer system compliance with 21 CFR Part 11 in a GMP pharma environment.
Strong understanding of laboratory operations, computer system validation, GAMP, and risk management.
data integrity, specialist, analyst, administrator, engineer, 21 CFR part 11, GMP, computer, IT