Requirements: English
Company: MindCapture
Region: Charleroi , Wallonia
Your Role in Driving Innovation
As a computer system validation (csv) consultant, you will play a critical role in managing and overseeing project deliverables for a variety of cutting-edge applications, with relation to the medical, pharmaceutical or biotech field. With your knowledge of data integrity and quality management, you will support the full lifecycle of computer systems whether it is focussed on local software systems in the lab or production environment or enterprise-level systems
How Youll Make an Impact
- Validation strategy development: design and implement validation strategies for computerized systems, including lab systems, manufacturing systems, and data management systems, in line with GMP, GxP, FDA, EMA, and other regulatory standards.
- Risk-based validation: conduct risk assessments to prioritize validation tasks and develop risk-based validation approaches for systems critical to product quality and safety.
- Validation documentation: develop and maintain essential documentation, including validation plans, protocols (IQ, OQ, PQ), traceability matrices, and final reports, ensuring completeness, traceability, and adherence to regulatory guidelines.
- Continuous improvement: identify areas for improvement in validation processes, proposing solutions that enhance efficiency and compliance across teams and systems.
- System audits: conduct regular audits of computerized systems to verify compliance, addressing gaps and implementing corrective and preventive actions (CAPAs) as needed.
What You Need to Bring to the Table
- You hold a masters degree in a scientific or engineering field (e.g., bio-engineering, bioinformatics, industrial engineering, civil engineering, etc.).
- You have some experience in the life sciences industry or with software-related projects.
- Nice to have: first expertise in CSV/Data Integrity.
- You have a strong affinity with IT, software, and systems.
- You are detail-oriented, eager to learn, and adaptable to new challenges.
- You possess strong technical and project management skills.
- You are responsible, with a strong analytical mindset and excellent problem-solving abilities.
Take your career to the next level - join us now!