Computer System Validation Specialist - Sweden
About Epista
Epista Life Science Sweden is growing and we are looking to add Computer System Validation (CSV) Specialists to our team in Sweden!
We’re a consultancy dedicated to continuously improving compliance and business in the Life Science industry. Since our founding we have expanded each year and we are present in several countries with more than 200 hard-working and fun-loving employees, that share many years of diverse experience, backgrounds, and interests. Epista has big ambitions for the future of Life Science, and we want you to be a part of it and help us achieve those goals.
If you're interested in becoming our next consultant, get in touch, we want to hear from you.
About the Job
With the new GAMP edition and recommendations from the FDA, it is now clear that they 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 come in. Epista’s team is growing and needs more consultant 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 asValidation 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
Your Qualifications
- A Master’s degree
- 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 will only be considering candidates residing in Sweden, as well as being eligible to work in Sweden.
On a typical day you might ...
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 system
- Share your experiences and lessons learned with the Epista team to make sure we are all continuously improving
Why work at Epista
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?
Want to learn more about working at Epista? Check out our website
You are welcome to send your application in Swedish.
NOTE: In line with the Swedish Law of discrimination, Epista Life Science Sweden AB will store relevant information for 2 years to be able to document a fair recruitment process for anyone applying for a role in Epista Life Science Sweden AB.
