On a typical day you would;

As a CSV consultant at Epista, you’ll be a part of the highly skilled team working at the intersection of business, compliance, and IT. You’ll be involved in a wide variety of projects, primarily focusing on acting as validation lead in system implementation projects and assignments, where you will contribute with your knowledge and expertise. Much of your time will be spent with clients – international pharma and fast-growing biotech companies. Your daily activities might include:

• Meeting with client’s Business owners, Quality process experts, and key Quality stakeholders (“speaking the lingo of Epista’s customer”) to identify needs, visions, and struggles
• Preparation and moderation of workshops with cross-functional participants
• Involvement in project status meetings, status presentations, or Steering Committees
• Development of validation strategies, prioritizing tasks, projects, and efforts to bring our customers from A to B
• Creation of client system validation documents
• Screening of IT application vendors, performing functionality evaluations, and giving final system recommendations
• Supporting customers throughout a system implementation, so they can make the right configuration/system design decisions
• Evaluating vendor assessment and vendor documentation
• Drafting System Governance documents to secure efficient and compliant management of validated system
• Share your experiences and lessons learned with the Epista team to make sure they are all continuously improving.