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.
- Provide interpretation and guidance for clients regarding software validation and related regulatory regulations/guidelines and Corporate and R&D site policies and procedures.
- Review/approve various software validation plan documents, test strategies, test documents, summaries, certification packages and associated deliverables as appropriate.
- Generate or review and provide feedback on various documents related to validation eg. calibration, SOPs, VMPs, etc.
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. 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. Minimum 3 years experience as either a QA software validation engineer or IT validation. 4-year college degree preferably in computer science or related field.
Synectics is an Equal Opportunity Employer.