Validation Analyst

4 weeks ago

Waukegan, United States Katalyst Healthcares and Life Sciences Full time
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.

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