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Validation Analyst

Patel Consultants Corp

This is a Full-time position in Somerset, NJ posted February 22, 2021.

Validation Analyst Requirements This position requires a minimum of a Bachelors in Computer Science, Life Science, or equivalent industry experience, and 7+ years of relevant technical experience including (but not limited to) 7+ years experience in validation analyst role 3+ years experience working in regulated biotech or pharmaceutical companies Responsibilities include Participate and contribute to the validation of software applicationsmodules and associated interfaces according to business needs and internal procedures (System upgrades, change control, retrospective validation). Prepare andor execute computer system validation documents Develop validation strategies Execute validation strategies Author validation documentation Review test scripts (Pre and Post execution) Perform Computer System Risk Assessments Complete Change Control Requests Interface directly with various Business and IT functional areas. Provide compliance and quality guidance to project team during and post implementation regarding CSV requirements. Provide guidance to Test Script WriterTester Experience in regulated environment (GLP, Google Cloud Platform or GMP) Experience in 21 CFR Part 11, GAMP Experience in SDLC (Agile or Waterfall) Provide guidance to project teams regarding the development of validation strategies Review and contribute to SOP revisions Execute Periodic Reviews of Computer Systems Non-technical Ability to be onsite for extended periods of time (3-4 weeks) Strong follow-through skills Excellent customer service skills ndash interfacing with scientists, interfacing with vendors and other IT groups Excellent Organizational Skills – ability to manage time and multiple tasks Excellent written and verbal skills Strong problem solving skills