Quality Systems Specialist
4 weeks ago
Are you a detail-oriented professional with a strong quality mindset and experience in digital validation? Do you thrive in a collaborative environment and have excellent communication skills? We are seeking a Quality Systems Specialist to join our team at Novo Nordisk A/S.
The Role
The Quality Systems Specialist will be responsible for specifying and designing the best possible solution for digital validation and ensuring business and quality requirements. This includes supporting the validation process, collaborating with key stakeholders, and managing maintenance activities.
Key Responsibilities
- Support Process Expert for validation, Process Owner, and Process Owner Delegate in managing the validation process with regards to digital validation.
- Collaborate with key stakeholders in the line of business, QA, system group, and suppliers.
- Ensure that current and new regulatory requirements are covered by the process.
- Manage and drive maintenance activities within the process in close collaboration with the IT System Manager.
Requirements
- Academic degree within IT, pharmacy, engineering, or other related fields.
- At least 5 years of experience from the pharmaceutical industry within IT, quality, or production.
- Experience working with IT qualification and digital validation in a regulated environment.
- Strong communication skills, with proficiency in English.
About the Department
The TIMS CoE is part of Investment Portfolio Quality Assurance, an area comprising around 250 highly skilled quality professionals who work to ensure early involvement in production facility investment projects. The primary objective of the TIMS CoE is to maintain, support, and develop the Novo Nordisk Test and Validation Tool, which has over 10,000 active users.
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