Intertwined

Systems Administrator (GMP, CFR Part 11)

Full Time
Silver Spring, MD, USA
Description

*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.


Responsibilities 

  • 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.


Requirements
  • 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.


To apply please send your application to mschroeder@thedenzelgroup.com


#IND1


data integrity, specialist, analyst, administrator, engineer, 21 CFR part 11, GMP, computer, IT

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