Role Description· implementation of the company continuous improvement plan; · proper validation/qualification of the facilities/equipment/systems according GMP guidelines;
As part of the QA department you will report to the Head of Quality. Under the direction of the reporting manager, you will continuously improve compliance systems, strengthen quality awareness and investigate quality related issues;
Responsibilities-contribute with continuous improvement: development and implementation of the Quality System & operational excellence; -re-qualification & re-validation regarding the state of facilities and systems; -collaboration and participation regarding equipment/ systems validation/ qualification projects; -provide guidance for the development of the validation approach; -documentation review/approval regarding equipment/systems validation/qualification; -as a member of the Quality department: deviations, CAPA's, change control, inspections/internal audits, compliance matters, system (risk assessment, assessment of validation / qualification needs);
Requirements-bachelor degree engineering (or similar); -more than 5 years experience with 3 years in an operational role in a GMP environment; -excellent GxP knowledge (in a regulated environment); -experience with risk assessment/validation/quality systems; -experience with problem solving, issue resolution and root cause analysis; -flexible and adaptable/independent/multitasking skills; -computer package knowledge (Microsoft Office, Excel); -knowledge of Quality Software Systems (Trackwise, Lab software) is a plus; -excellent knowledge of English & French language;
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.