IT Validation Specialist
2 weeks ago
At Novo Nordisk A/S, we are driven by a passion for improving patients' lives. As a company that produces half of the world's insulin and biopharmaceutical products, we are committed to delivering high-quality solutions.
We are seeking an experienced IT Validation Specialist to join our M3 IT/Automation department team. In this role, you will play a critical part in defining the validation strategy, planning, and reporting for specific implementations of IT systems or computerized equipment with an impact on GxP (healthcare).
Your responsibilities will include participating in large-scale expansion projects as the IT/automation validation expert, taking responsibility for validation activities, providing help in developing and optimizing our approach to validation and quality control work, and performing various assessments such as Supplier Assessment and IT risk assessment.
To succeed in this position, you must have a minimum bachelor's degree in Automation, IT, biotechnology, production engineering, or a similar field, experience within validation from pharma industry or other regulated industries, GxP compliance experience, preferably also in working with Good Automated Manufacturing Practice (GAMP), and fluency in verbal and written English.
About the Position
- Participating in large scale expansion projects as the IT/automation validation expert thus responsible for execution of validation and quality control activities.
- Taking responsibility for validation activities for the project(s) e.g., planning, documentation, coordination, and reporting and ensuring that these are executed effectively.
- Providing help in developing and optimizing our approach to validation and quality control work, ensuring we verify and validate the right things at the right level, supporting a risk-based approach to verification.
- Performing various assessments such as Supplier Assessment and IT risk assessment or facilitating the workshops for these activities.
- Ensuring the validated state of the system(s) by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in corporation with the system managers and IT responsible when needed and that systems are following relevant internal and external regulatory requirements.
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