GMP compliance officer
Onze klant in de regio Wetteren is een gerenommeerd farmaceutisch bedrijf. Ze zijn actief in ontwikkeling en productie van fine chemicals voor de farmaceutische industrie.
Momenteel zoeken zij een GMP compliance officer
- You stay abreast with external GMP and regulatory and customer requirements and you ensure that these requirements in the GMS remain up to date with the latest standards.
- You implement and audit them in daily operations, in order to ensure that the GMS is compliant with the requirements, with as final goal to guarantee that AON’s final products are safe for the end-user and comply with the requirements.
- You ensure a qualitative and efficient management of authority inspections and customer audits.
- You ensure an adequate CAPA management.
- You ensure business continuity according to regulatory, market and customer standards by managing compliance activities.
- You make sure that continuous improvement is embedded in your own performance and the organisation. You understand and apply OE concepts and tools.
- You possess a Master or Engineering degree in Chemistry / Sciences.
- You have a profound knowledge of GMP.
- You have gained several years of relevant professional experience in an industrial environment.
- You possess a proven track record of project and change management skills.
- You have an analytical mind with a good ability to synthesis the core of a subject.
- You are an excellent communicator in Dutch and English (spoken and written).
- You organise your work efficiently.
- You know how to deal with pressure and deadlines.
- You possess excellent IT-skills (eg Outlook, Word, Excel, Powerpoint,…). Preferable you also have knowledge of SAP and Sharepoint.
- Proven experience with Operational Excellence (Lean/sigma) is an asset.
Els De Meester