About Epista
Epista Life Science is growing and we are looking to add a computer software Validation Lead to our team in Sweden!
We’re a consultancy dedicated to continuously improving compliance and business in the Life Science industry. Scince our founding we have expanded each year and we are present in several countries with 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 Validation Lead, get in touch, we want to hear from you.
About the Job
We are looking to add a Validation Lead to our team in Stockholm - Sweden, to help guide our customers through times of change and support them in implementation and operations of Business Applications.
Are you passionate about quality assurance for Business Applications? Would you find it interesting to develop and define best practices for validation of Business Applications and IT infrastructure, bringing your innovative spirit to our organization? Then you could be our new colleague - read more and apply!
Depending on your expertise, you may work with:
- Perform IT/QA readiness assessments and create Validation Strategies
- ERP System Implementation and support –take the role asValidation Lead in implementation and support projects. Planning, executing, supporting validation activities
- Validation Advisory – act as SME for advisory within CSV and CSA
- Cloud Validation – Set Cloud Control Strategies and Cloud Vendor Management
Your Qualifications
- At least 5 years of experience of in IT compliance, computer system validation or similar in the Life Science industry
- Experience in IT QA/QC in the pharmaceutical industry
- Knowledge of GAMP5, FDA CFR 21 Part 11, EU GMP Guide Annex 11
- High level of expertise in at least one of the following:
- CSV
- CSA
- Strong consultancy mindset including excellent communication and presentation skills.
- Consulting skills, ability to identify and solve problems, provide guidance and support. This requires both analytical and creative thinking, as well as the ability to communicate effectively with clients
- Ability to work on multiple smaller projects at the same time and properly prioritize actions
- Outgoing personality that can facilitate working sessions with various different business stakeholders
- A desire to continuously improve your clients, your colleagues, your company, and yourself
- 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
- Experience with Business Applications Validation would be considered as advantage
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 Validation Lead 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 Business Application implementation and operations projects and assignments, where you will contribute with your knowledge and expertise. Your daily activities might include:
- Taking Validation Lead role in large Business Application implementation projects, providing customers with strategic advice on compliance with regulatory requirements, audits and process improvements of IT systems, ongoing maintenance, and operation
- Meeting with client’s Business owners, Quality process experts, and key Quality stakeholders to identify requirements, gaps, issues and provide guidance
- Work collaboratively across functions with stakeholders and vendors to plan, coordinate and execute Business Application validation activities
- Preparation and moderation of workshops with cross-functional participants
- Being a communication bridge between departments (IT, Business, Quality)
- Development of validation strategies, prioritizing tasks, projects, and efforts
- Support for client in relation to system validation documents
- Screening of IT application vendors, performing functionality evaluations, and giving final system recommendations
- Evaluating vendor assessment and vendor documentation
- Supporting customers throughout a system implementation, so they can make the right configuration/system design decisions
- Drafting system operational 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
- Create overall compliance and validation strategies on both project and company level
- Independently orchestrating and managing validation/qualification projects
- Participating in projects as a Validation & Compliance Advisor to ensure compliance and documentation requirements are met
Why work at Epista
Epista is a team of pioneers. We 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 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?
