Validation Coordinator
- Neder-Over-Heembeek
Define, coordinate and guide the overall qualification & validation strategy & processes in line with project specifications . To be the link between Qualification and Validation. * 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 the implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation).
Define, coordinate and guide the overall qualification & validation strategy & processes in line with project specifications . To be the link between Qualification and Validation. * 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 the implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation).
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