Katalyst Healthcares and Life Sciences
Validation Analyst
Katalyst Healthcares and Life Sciences, Gurnee, Illinois, United States, 60031
Responsibilities:
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. Responsibilities:
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.
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. Responsibilities:
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.