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Validation Analyst
4 months ago
- Lead/support validation efforts and deliverables for projects requiring validation.
- Create and execute validation test scripts and document test results in accordance with standards.
- Review and evaluate validation assessments for application systems/projects.
- Review/revise Validation Policy and SOPs as directed.
- File validation documentation within following Quality Assurance Library guidelines.
- 7-9 years of experience.
- ssociate degree minimum or equivalent combination of education and work experience.
- 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.
- Minimum 2 years' experience with validated systems within a regulated industry.
- Experience writing Standard Operating Procedures and validation policies.
- dvanced knowledge and understanding of IT concepts and word processing and spreadsheet skills.
- Laboratory, product, and manufacturing knowledge/experience are a plus.
- Outstanding verbal and written communication skills, Customer Service Focused; Information Technology background, experience within a Quality/Regulated environment; System Audit /Validation background/experience; excellent organizational and project management skills including SDLC.
