IT Validation and Compliance Consultant 12 Months Contract

• Work closely with Product Owners and delivery teams, to provide quality guidance, and drive alignment,
• Participate in a large scale and business critical digital product as the validation expert and the execution of validation and quality control activities,
• Collaborate with your colleagues and take responsibility for validation activities for the product e.g. planning, documentation, coordination and reporting and you are quality-minded with good ability to execute within deadlines,
• Help develop and optimize our approach to validation and quality control work, ensuring we test and validate the right things at the right level, supporting an efficient risk-based approach to testing, while continuing to ensure an inspection ready solution,
• Drive and execute the product’s test automation and take the lead on increasing our level of test automation,
• Plan and lead the validation activities for our custom build IT solutions, including preparing validation plans, conducting risk assessments, design review meetings and reports, and reviewing and approving technical specification and verification records,
• Work together with IT QA and project validation lead to find the right level of validation activities, ensuring that the validation meets internal and external requirements for GxP critical IT solutions,
• Be part of an agile transformation and advocate for agile ways of working in and across the company.
• Work with colleagues which are spread all over Europe so the bulk of the work will be handled online.

To be successful in this role, we believe that you should have:

• You have a degree within Computer Science, Engineering, Software Development or other related fields,
• You have experience within IT validation from the pharma industry or other regulated industries, and preferably with validation of solutions processing GxP critical data in an agile (SAFe) context,
• Familiarity with test automation and tooling together with software development and CI/CD processes (e.g. Azure DevOps) are considered an advantage,
• Ability to explore and adopt new technologies, supporting validation deliverables and activities,
• Strong communication skills and the ability to convey complex technical concepts to non-technical stakeholders,
• As our corporate language is English, we expect you to be fluent both in writing and spoken.

Required Skills

• You have a degree within Computer Science, Engineering, Software Development or other related fields,
• You have experience within IT validation from the pharma industry or other regulated industries, and preferably with validation of solutions processing GxP critical data in an agile (SAFe) context,
• Familiarity with test automation and tooling together with software development and CI/CD processes (e.g. Azure DevOps) are considered an advantage
• Ability to explore and adopt new technologies, supporting validation deliverables and activities,
• Strong communication skills and the ability to convey complex technical concepts to non-technical stakeholders,
• As our corporate language is English, we expect you to be fluent both in writing and spoken.

Start date: 1/12-2024

End date: 31/12-2024

Location: Søborg