Pretius is seeking a dedicated Computerized System Validation Specialist to join an international project within the financial industry. You will play a crucial role in ensuring that our systems meet rigorous regulatory standards while maintaining high-quality documentation throughout the validation lifecycle.
Key responsibilities
- Assess validation gaps and recommend effective remediation activities for computerized systems.
- Facilitate risk assessments for systems operating in regulated environments.
- Create, review, and remediate essential validation documentation, including plans and reports.
- Manage requirements traceability and ensure GxP compliance throughout the project.
- Support Operational Qualification and Performance Qualification testing activities.
- Prepare audit-ready validation evidence for internal and external inspections.
Requirements
- At least 3 years of hands-on experience delivering Computerized System Validation projects.
- Practical knowledge of GxP regulations, validation methodologies, and GAMP 5 guidelines.
- Mandatory previous experience in the pharmaceutical or life sciences industry.
- Strong analytical mindset with the ability to critically review technical documentation.
- Excellent communication skills in English and the ability to work independently.
What we offer
- A focus on long-term professional relationships based on fair principles and reliability.
- Co-financing for private healthcare and sports activity cards.
- Access to internal courses, professional conferences, and certification opportunities.
- Regular team bonding activities to foster collaboration and growth.