Vacancy expired!
- Create and/or review computer system validation schedules, risk assessments, requirement specifications, protocols and reports, test scripts, traceability matrices, and validation summary reports that utilize test strategies commensurate with regulatory risk. Review applicable procedures and system training manuals as applicable. Review vendor provided documentation for suitability.
- Participate in project team meetings with IT and Business as required (May involve early morning and/or evening teleconferences with global project teams). Provide input to the project manager for all validation activities and deliverables
- Define the scope and complexity of computerized system validation projects based on system and functional risk analyses.
- Develop requirements for business requirements, system security, user roles, workflows, data flows, GxP regulations and how these systems fit into the larger IT infrastructure.
- Work with IT and User Groups to evaluate change control requests, assess regulatory risk associated with such requests and determine the corresponding validation requirements for such changes.
- Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or equivalent.
- Minimum 8 years of experience validating complex systems and writing CSV test scripts, protocols and summary reports in an FDA regulated biotechnology, pharmaceutical or medical device company.
- Knowledgeable of FDA/EU/MHLW Regulatory Requirements and industry best practices for computerized system validation.
- Understands lifecycle approach and risk-based approach to validation.
- Familiar with GXP regulations for drugs and combination products particularly in the Google Cloud Platform and quality areas.
- Experience validating systems used to support Google Cloud Platform business processes preferred.
- Familiar with Information Technology principles, functionalities, and capabilities of computer systems; and how computer systems relate to and integrate with larger corporate IT infrastructures.
Vacancy expired!