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IT Compliance Specialist

2 months ago

Runcorn Cheshire, United Kingdom Fresenius Kabi UK Full time
Job Description

The Company

Fresenius Kabi is a global healthcare company that specialises in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used worldwide to help care for critically and chronically ill patients.

The Fresenius Group employs c.400,000 high-calibre professionals across the world, with a workforce of circa.1,000 professionals across the UK & Ireland.

As an IT Compliance Specialist, the main role of the IT compliance Specialist is ensuring the Health Cloud system remains in control through small and large changes during the rollout. The position is full-time Monday - Friday and is based in Runcorn Cheshire, with the option of hybrid working.

Responsibilities

• Understand and digest Fresenius Kabi’s global validation SOPs for validation of a cloud-based system provided on a SaaS basis through Salesforce

• Work with our Validation consultants to build a validation framework that is tailored to Health Cloud and it’s need for constant improvement and innovation

• Accountability for the development of Health Cloud Validation procedures to ensure that current regulatory compliance and company objectives are maintained

• Act as validation owner for Health Cloud and it’s associated clouds including risk identification and mitigation, responsible for tracking changes through to completion

• Preparing and executing validation protocols, reports and effectiveness reviews

• Provide support and assessment for relevant quality deviations

• Author SOPs and Work Instructions relevant to the operation, maintenance and compliance of Health Cloud

• Responsible for working with IT staff to maintain the compliance of Health Cloud throughout the lifecycle in accordance with site policies and procedures including periodic review

• Ensure that proper CSV procedures are followed during Health Cloud implementations and provide CSV support for new projects throughout project lifecycles

Experience/qualification

• A mind set and aptitude to understand Health Cloud technology and an ability to continually learn and improve your understanding through ongoing formal and self-driven training

• Ability to work in a fast paced environment, where short notice changes in priority may be required

• A good communicator who can translate technical language into easily understandable business language

• Be collaborative across all business areas with a ‘can do’ attitude

Benefits

  • Contributory Pension Scheme (rises with service)
  • Role specific tailored training and development plan
  • Life Insurance (4 x salary, death in service)
  • 25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidays
  • Maternity, Paternity and Adoption Leave
  • Professional fees paid
  • Bike to work scheme
  • Long Service Awards
  • Employee Assistance Programme
  • Free onsite parking and subsidised canteen
  • Blue Light Card
  • Charity Fundraising & Volunteer Days
  • Company funded family days out

We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.