Description
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 SOP's as directed.
- File validation documentation within following Quality Assurance Library guidelines.
COMPETENCIES:
- 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.
- Associate Degree minimum or equivalent combination of education and work experience.
- Minimum 2 years experience with validated systems within a regulated industry.
- Experience writing Standard Operating Procedures and validation policies.
- Advanced knowledge and understanding of IT concepts and word processing and spreadsheet skills.
- Laboratory, product, and manufacturing knowledge/experience are a plus.
Must have experience with 21 CFR Part 11 - Quality Center experience a plus