Computer System Validation Specialist

4 days ago

Hørsholm, Denmark HR-ON Full time

With the new GAMP edition and recommendations from the FDA, it is now clear that the Life Science industry is moving away from CSV and confidently towards Computer Software Assurance (CSA). That means that more and more companies will need help transitioning their efforts to meet updated best practice standards.

Epista’s team of experts have an abundance of experience working with CSV and with the updated guidelines, more and more Life Science companies will need help applying them to their businesses. That is where your expertise comes in. Epista’s team is growing and needs more consultants with CSV experience to help our customers stay in compliance.

We are expanding our service capabilities, so we're looking to add CSV consultants to our team to help guide our customers through times of change.

Depending on your expertise and interest, you may work with:

  • Computerized System Implementation – Take the role as Validation Lead in implementation projects
  • Risk Based Approach – Lead with a risk-based validation strategy maximizing the use of vendor documentation where appropriate
  • Validation Advisory – Act as SME for advisory within CSV and with a future focus on CSA
  • Cloud Validation – Set Cloud Control Strategies and Cloud Vendor Management

Epista Life Science (Epista) is a trusted consulting company specializing in business process and IT services for the Life Sciences industry. Since our establishment in 2009, Epista has grown remarkably, expanding our services across Denmark, Sweden, Switzerland, Germany, and the US. Throughout our journey, we have consistently maintained outstanding employee and customer satisfaction. In 2022, we partnered with FSN Capital Partners, reinforcing our commitment to developing a global services platform dedicated to Life Science companies. With FSN onboard, we are looking forward to exciting market expansions as well as merge & acquisition activities.

  • 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 can facilitate working sessions with various different business stakeholders
  • Driven, result-oriented, ambitious, and can work independently
  • A desire to continuously improve your clients, your colleagues, your company, and yourself
  • Bonus:
    • Experience with Cloud System Validation
    • Experience with the Veeva Platform

You’re trustworthy, have a high degree of situational awareness, and a flair for communicating with a variety of personalities. This is important because it ensures your image as a credible partner for Epista’s clients.

For this position, we are only considering candidates residing in Denmark, as well as being eligible to work in Denmark.

As a CSV consultant at Epista, you’ll be a part of our 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 our 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 our 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 systems
  • Sharing your experiences and lessons learned with the Epista team to make sure we are all continuously improving

At Epista, we consistently work together to unlock each consultant’s potential to continuously improve. We pioneer new ways to stay in control of patient safety and product quality and question the status quo in everything we do.

Our unique team spirit makes a positive impact – on our team, our clients, and the Life Science industry. Here, you’re never alone. We all work together for everyone’s success. And each individual is strengthened by the knowledge of the group.

We’re proud to be Epista, for good reason. If you’re the cream of the crop, are you ready to join us?

#J-18808-Ljbffr

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