• tech observer
  • Woodcliff Lake , NJ
  • Information Technology
  • Full-Time
  • 8 Dorchester Rd

Essential Functions
Responsibilities Percent of Time
1. Review (and approve) computer system validation and related documentation generated for three essential ongoing projects for compliance with 21 CFR Part 11 and associated guidelines 70%
2. Provide expert CSV advice as necessary for the above three projects, to help ensure the validation will pass a health authority inspection 15%
3. Provide validation review and approval, and expert CSV advice, for other validation projects as well as for controlled changes to existing validated systems, as time allows. 15%

Scope Measures
Quantitative measures of impact:
Numbers of validation documents reviewed and approved
Number of change controls reviewed and approved
Number of deadlines met

Knowledge/Skills/Abilities Required
Bachelor s degree in associated functional discipline
Experience with computer system validation projects, preferably in a clinical research environment, for at least 3 years
Knowledge of 21 CFR Part 11, GAMP 5, and Annex 11
Quality Assurance experience, in addition to the above, preferred but not required
No travel required
The position will require independent decision making for (but not limited to) the following:
Acceptability of validation documentation including completed test scripts
Providing solutions to unexpected developments
Associated topics: business advisory, business systems, client, consultant, crm, information technology consultant, sales, sap, senior consultant, support analyst

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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