Senior IT Quality Validation Consultant (19-00689) – NJ – Woodcliff Lake

Senior Manager – Validation
Provide independent quality oversight via document review primarily for three high impact ongoing computer system validation (CSV) projects, as well as potentially for some minor ones. This will temporarily replace a member of CQA who is leaving Client, and ensure that the projects are completed on schedule (one as promised to health authorities).

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
Source: Job Diva – Job Listing

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