Pharmaceutical IT CSV SME

Job ID: 133000 Industry: Pharmaceutical


Pharmaceutical IT CSV SME

Project Description:

Our client is a leading gene therapy organization looking for an experienced Computer Systems Validation and IT specialist to help with for a large IT Infrastructure Network Qualification initiative.

Day to Day Responsibilities:

The client is looking for an experienced Computer Systems Validation Specialist to assist in the overall development, qualification, and maintenance of an entire IT Infrastructure network.  This person will be managing the IT from a qualification perspective.    The client has many business units that it wants to get into the same database, however they want to make sure the database software/hardware is all compliant to FDA rules and regulations.   The consultant must be a SME in 21 CFR part 820, and GXP in order to properly put together a quality plan for database infrastructure network.  Primary responsibilities will include writing SOP’ s/Work Instructions/Templates.

  • Computer Systems Validation
  • IT Infrastructure  
  • 21 CFR Part 11
  • GAMP 5
  • B.S. Degree Computer-Systems, Information Systems, or Computer Engineering
  • Pharmaceutical / Medical Device background  

Job Type: Contract  

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