Los Angeles Area
We are seeking a talented Computer Systems Validation (CSV) Consultant for an on-site client assignment to support Quality Management Systems including all documentation and processes involved in maintaining the validated state through continuous change requests, application upgrades and other support as needed.
Essential Duties and Responsibilities
- Manage the CSV life cycle, coordinate and manages functional, user acceptance, validation and performance testing and provides technical support as needed
- Participate in the establishment of QA and Validation strategies, needs/requirements and associated plans and activities.
- Partner with IT, QA and Business teams in the development, implementation, project management, release, review and maintenance of system including development of processes and related tools.
- Conduct risk assessment and monitor system compliance.
- Prepare Functional and Technical specifications related to regulatory requirements and risk/impact.
- 5+ years' CSV experience in a regulated environment including knowledge of GxP regulations with proficiency of system validation and quality activities.
- Bachelor's Degree in Computer Science or equivalent combination of education and experience.
- Strong experience/Expertise with Mastercontrol and background in Quality Management Systems e.g. TrackWise
- Technical proficiency with QMS related applications such as MasterControl, TrackWise, etc.
- Strong analytical, problem solving and communication skills