Soortgelijke vacatures
Hands-on attitude, motivated, accurate and responsible in defining, coordinating and guiding qualification & validation strategies & processes in line with project specifications in cooperation with the project team, internal & external stakeholders.To be the link between Qualification and Validation.
Jouw verantwoordelijkheden
- 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 our projects 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 (URS, Risk & impact Assessment, VMP, design review qualification, test matrices, IQ/OQ/PQ Protocol, IQ/OQ/PQ Report,…).
- Organize, execute and document CQV testing.
- Support during system/installation start-up in function of CQV test 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.
- Build a strong partnership with key stakeholders; both internal & external
Jouw profiel
- Masters 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, current Industry standards, regulatory requirements and Authority expectations regarding CQV.
- You have a good Comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry.
- Use a risk-based approach for problem solving and prioritization of tasks.
- Blow a quality and compliance mindset through the validation activities.
- You have a field experience with: System start-up and CQV, Project scheduling, Change management, Project document management
- Good team player in order to succeed in the validation project, who can also work independently.
- You speak and write fluent English, Dutch and/or French
Ons aanbod
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