Validation Officer - Brussels, België - LaCAR MDx Technologies
1 maand geleden
Beschrijving
LaCAR is a young biotech company, active internationally, that develops, produces and commercializes worldwide CE-IVD diagnostic kits for genetics and new-born screening.
Headquartered in the Liège Science Park (Belgium).Role and tasks:
As a
Validation Officer you will contribute to the establishment and the regular updating of the technical documentation (IVDR compliant).
Your responsibilities as validation officer include:
- Plan and perform validation protocols for new and existing products
- Analyze validation data and generate comprehensive reports
- Develop and maintain technical documentation related to validation and ensure that updates are available
- Stay uptodate with evolving regulatory guidelines and best practices related to validation in the biotechnology sector
- Participate to risk assessments and change controls
Profile:
Must have
- Master's degree in science or engineering discipline (e.g., Chemistry, Biotechnologies, Chemical Engineering), or equivalent through experience
- Technical skills on immunoassays, molecular biology and/or mass spectrometry
- Strong analytical skills, well organized, studious, and precise
- You enjoy managing documentation: creating, reviewing and updating documents, and followup on their approval
- English : good knowledge (B2)
- Proven experience in validation activities within the biotechnology industry
- Knowledge on the ISO13485 and IVDR 2017/746 regulations are a plus
Offer:
- The opportunity to really enjoy your workyou make the difference.
- A fastgrowing environment. Your job evolves with the company.
- We develop products for a healthier world. What matters is what we do.
- A varied job. Days follow each other but are never alike
- Fun teambuilding events
- Flexible hours. Flexible salary package.
**Permanent contract (38h/week)
- An exceptional working environment with a view over the woods of Sart-Tilman (Liège), as well as a south-facing terrace for afterwork events.
- Free fruits at the office. Free-SoupTuesdays
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