Life Sciences Consultant

20 hours ago


Hørsholm, Hørsholm Kommune, Denmark HR-ON Full time

At Epista Life Science, we specialize in business process and IT services for the Life Sciences industry. With extensive experience working with legacy systems and navigating complex regulatory requirements, our team has developed a deep understanding of the challenges facing companies in this sector.

The new Computer Software Assurance (CSA) guidelines and recommendations from the FDA have sparked a shift away from legacy systems towards a more modern approach. As a result, companies are in need of experts who can help them transition their efforts to meet updated best practice standards.

Key Responsibilities
  • Meet with client representatives to identify needs, visions, and challenges
  • Prepare and moderate workshops with cross-functional participants
  • Involvement in project status meetings, status presentations, or Steering Committees
  • Develop validation strategies and prioritize tasks to drive project success
  • Create client system validation documents
  • Evaluate IT application vendors and vendor documentation
  • Support customers throughout system implementation, ensuring efficient and compliant system design decisions

As a CSV consultant at Epista, you'll be part of a highly skilled team working at the intersection of business, compliance, and IT. Your daily activities may include:

We strive to unlock each consultant's potential, stay ahead of patient safety and product quality concerns, and question the status quo in everything we do.

Requirements
  • At least 5 years of experience in the Life Science industry
  • High level of expertise in at least one of the following:
    • CSV
    • CSA
  • Outgoing personality that facilitates effective communication with various stakeholders
  • Driven, result-oriented, ambitious, and able to work independently
  • A desire to continuously improve yourself, your colleagues, your company, and your clients


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