Process Validation Specialist (h/f)

What are your responsibilities? As Process Validation Specialist, you are in charge to Perform Quality by Design on the drugs to be transferred or developed on the site. Develop the appropriate validation plan based on the deduced CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters). Ensure that all qualifications and validations are performed according to the regulatory and customer requirements. Be an expert for the validation of aseptic process (formulation, filling, holding times). Ensure that all activities are performed in time and due quality. Write qualification and validation protocols/reports and other documentation related to the activities. Investigate deviations as needed and execute corrections. Define and execute improvement projects and initiatives. Participate in customer and authority audits. Participate to shutdown qualification & calibration activities. Can be involved in other process validation activities.

Profiel

Who are you? You are graduated as a Master degree in Science or Engineering. You have min 7 years experience in GMP environment and 5 years experience in a similar role. An experience in Quality by design is a must. You fluently speak French and English.

Talenkennis