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About the role
- Senior Test and Validation Manager focusing on ERP systems validation and testing for Demant. Ensuring compliance with IT QMS and regulatory standards in the medical field.
Responsibilities
- Develop and drive end-to-end validation strategy for ERP systems, including planning, execution, and approval of validation deliverables.
- Ensure adherence to SOPs for IT Computerized System Validation and HIQMS compliance.
- Oversee creation and review of validation documentation (e.g., Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix).
- Define and lead the testing approach for ERP implementation, including functional, integration, and performance testing.
- Establish test protocols, manage test environments, and ensure traceability between requirements and test cases.
- Maintain validated state of systems during operation and manage change requests impacting validation scope.
- Collaborate with Quality Assurance and IT Compliance and Validation teams to ensure regulatory compliance.
- Work closely with Project Managers, Solution Architects, Business System Owners, and external vendors to align validation and testing activities with project timelines.
- Provide expert guidance on risk-based validation strategies and testing best practices.
Requirements
- Proven experience in IT system validation and testing ideally within regulated environments (GxP, EU-MDR, FDA).
- Strong knowledge of ERP systems (preferably Microsoft Dynamics 365 Finance & Operations or similar).
- Familiarity with validation frameworks (IQ/OQ/PQ), risk-based approaches, and documentation standards.
- Excellent leadership, communication, and stakeholder management skills.
- Nice to have: previous experience with Annex 11 and GAMP principles in production and medical environment.
Benefits
- full-time work agreement in an international organization;
- possibilities for learning and development opportunities, adapted to your needs and supporting your growth;
- hybrid work model, combining remote work opportunities with work in an office in the Szczecin City Center;
- flexible working hours;
- benefits package including social benefits (private medical health care, insurance, sport card, etc.);
- Scandinavian culture – we are informal and care about equality, independence, open dialog, and work-life balance.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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