Quality Assurance and Validation Expert
We are seeking a highly skilled Quality Assurance and Validation Engineer to join our team in Belgium. This role will be responsible for establishing and executing qualification protocols, writing technical documentation, and participating in the qualification of systems.
About the Role:
* Develop and execute qualification protocols; IQ, OQ, PQ
* Write technical documentation including equipment risk assessments, validation plans, and qualification reports
* Participate in the qualification of systems such as HVAC, clean utilities, process or lab equipment
* Coordinate qualification execution activities, including external vendors and internal departments
* Manage associated qualification deviations and CAPAs
Requirements:
* Masters degree in sciences or engineering or equivalent experience
* At least 4 years of experience in equipment qualification (IQ, OQ, PQ)
* Previous work experience in the Pharmaceutical, Biotech, or Medical Devices sector
* Good analytical, organizational, time management, and problem-solving skills
* Good writing skills, able to develop SOPs and create final reports
* Solid knowledge of current FDA and EU regulations and best practices
What We Offer:
* A human-sized company with great colleagues from diverse backgrounds
* An open communication culture that values feedback
* A team environment where every member is valued and appreciated
* Opportunities for growth and development within an international and multicultural environment
* Continuous learning and development opportunities
* Competitive salary package and exceptional employment benefits