I.T. Systems Validation Expert

I.T. Systems Validation Expert

Responsibilities:

• Develop project validation plans and generate summary reports

• Evaluate risk assessment and functional requirements specifications (FRS)

• Act as liaison between quality assurance and project team

• Help drive each phase of the project lifecycle including ascertaining requirements, risk assessment, change / release management

Qualifications:

• Bachelors degree in business / I.T. or comparable education & experience

• 5 years minimum experience in computer systems validation including authoring and execution of IOQ/PQ’s and strong familiarity with cGMP/GLP/GAMP5/GALP.

• Must be familiar with all phases of a systems development life cycle.

• SAP, LIMS , Empower would be considered assets