Description
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. 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. 4-6 Yrs Exp.
Comments:
- Ability to run SQL query and understanding Oracle tools such as TOAD
- Quality Center v10.0
- 3-5 years of testing experience, protocol authoring and execution, defect documentation will require
- Supply Chain experience is a plus
SKILLS
NA
Synectics is an Equal Opportunity Employer.