What are the responsibilities and job description for the CSV Engineer position at vTek Systems Inc?
Job Title: CSV Engineer
Location: Boston, MA
Essential Skills: CSV Consultant for QC systems
Skills: Life Sciences : Computer System Validation
Must-Have
1. Lead project compliance work streams, responsible for end-to- end quality and compliance aspect of the project, validation deliverables, client buy-in and reporting leading to successful project delivery and client delight
2. Engage with key stakeholders for execution of day-to-day interactions with client teams
3. Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5 and SOX IT
4. Subject matter expertise in areas such as Quality Management, Document management and Change Management
5. Establish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
6. Knowledge of various Testing tools used throughout the Pharmaceutical industry
7. Must have global client exposure and have worked in Global delivery model