What are the responsibilities and job description for the Analyst QA II position at JMD Technologies Inc.?
Analyst QA II
Location: Plainsboro, NJ (hybrid)
Duration: 12 months
Skills
* IT QA
* Strong knowledge of regulatory guidelines and standards related to computer system validation in the pharmaceutical industry (e.g., FDA 21 CFR Part 11, GAMP 5).
* Experience in validating computerized systems used in pharmaceutical industry.
* Knowledge of validation methodologies, risk assessment techniques, and validation documentation practices
* Provide compliance guidance across IT and stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment.