Validation and Regulatory Quality Associate

Job Title : Validation and Regulatory Quality Associate
Job Location : Puurs, Belgium
Job Type : Contract

Role Description

Responsibilities:
• Monitoring the validation and registration approach for all equipment (filling lines, autoclaves, inspection machines, HVAC, computer systems, lab systems, ...) of a complete production unit.
• Contact point and the quality authority for validation and compliance within this production unit. The consultant is an active part of a team of project engineers quality, each with a focus on a certain production unit, which share knowledge and fall for each other.
• Contact point in the team for certain processes (eg HVAC, sterilization, calibration, ...) for which the consultant builds the expertise through contacts with the departments involved.
• The consultant is involved as validation and registration authority in investment projects for modifications and new installations.
• Focus on product quality and compliance, guiding the project team and ensuring general awareness.
• Evaluation as quality authority with each change the validation and registration impact in change controls.
• Collaborate with the technical experts on a validation plan and final review of all system validation reports.
• Coordination with global registration colleagues and the experts of the site to prepare a new registration dossier for new submissions and modifications to existing registration dossiers.

Qualifications
• Master of Science: Bio-Engineer, Industrial-Pharmacist, Industrial Engineer, ...
• Broad field of interest combined with a natural affinity for quality and processes.
• Professional approach in communication with various departments and possess the necessary assertiveness to defend your viewpoints.
• Critically set but works constructively towards solutions.
• Working independently and making decisions, and actively discussing issues with colleagues.
• Always keep a "helicopter view", but dive into the details when necessary.
• Good at setting priorities, and stress resistant.
• Preferably a few years of work experience in at least one of the following environments:
• Engineering in a GMP environment
• Quality department
• Testing and validation