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Validation Analyst
1 month ago
Manager is looking for the below:
- Responsible for following ADC quality system procedures for non-product computer systems validation, primarily SaaS validation.
- Including project management, risk assessment, requirements definition, testing and all documentation.
- Identifying and working with / taking directions from system owners, subject matter experts, and quality approvers.
- Must have significant experience in medical device computer systems validation, including SaaS, in compliance with FDA requirements.
- Must have experience with validation of 21 CFR Part 11 requirements.
- No education requirements but must have high school diploma or GED
- This is not a Software/Systems tester position but a position where the candidate will be responsible for soup to nuts validation which will include project management, risk assessment, requirements definition, testing and all documentation. So will not be just IQ, OQ PQ etc.
