Computer Stystems Validation Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Our client, located in Berkeley Heights, New Jersey, is seeking a Computer Systems Validation Manager to perform the following duties: Maintain computer systems in compliance with policies, guidelines, and procedures Supervise electronic records management Assist key customer groups in the operation of application software Conduct training of staff regarding computer validation, electronic records management, and other Quality Assurance topics Prepare and execute computer system validation documents Perform compliance assessments of computerized systems Supervise the daily activities of junior staff and responsible for validation project management Qualifications: BS or BS/MS degree in Computer Science, Chemistry, Life Sciences or Engineering 7-10 years experience in Information Technology Experience with GxP regulations, GAMP, and good documentation practices Knowledge of analytical laboratory data systems or manufacturing automation Knowledge of clinical systems Knowledge of computer network and system security principles Experience with 21 CFR 11 Experience creating and executing computer systems validation documents Ability to interact effectively with laboratory, QA, and IT groups 5 years experience in FDA-regulated industries and 7-10 years computer automation/validation experience Preferred Skills/Knowledge: 2 years experience creating SQL + queries under Oracle 8i or newer 2 years experience creating reports using Crystal Reports 10 or newer 2 years experience performing manual/automated testing using tools such as Mercury Quality Center
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