Ensure correct and state of the art Qualification/Validation approaches, to establish the Validation Plan and be accountable for all cGMP decisions taken during the Validation of the Investment project starting with the Design Qualification step and ending with the establishment of the Validation Summary report.
To ensure oversight of the qualification (IQ, OQ, PQ) and validation (PPQ, CV, PV) activities.
Responsible for writing, reviewing and approving validation documents (Risk Assessment, PQ Protocol, PQ Report,…).
Responsible for coordination of PQ execution activities.
Responsible for the implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation).
Responsible for the implementation of adequate validation strategy in compliance with FDA, EMEA and International quality standards.
Responsible for assuring inspection readiness – regarding Validation
Responsible for smooth handover from PPQ/Process Validation to production (Training, SOPs etc.)
Assistance with requirements of Equivalence Reports, Equipment Family Reports, etc.
University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
Expert in the field of quality/validation activities & control tests, cGMP and EMA/FDA
Understanding of good practices in biopharmaceuticals
Experience in Pharmaceutical production environment, process validation, equipment validation
Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
Use a risk-based approach for problem solving and prioritization of tasks.
Blow a quality and compliance mindset through the validation activities.
Strong communication, organizational and influencing skills to work transversely.
Good team player in order to succeed in the validation project
You speak and write fluent English, Dutch and/or French
Must work independently with minimal supervision and schedule tasks in time so the project can be delivered on time.