QA Officer

Contenido de trabajo

Function

• You manage the project portfolio of new and existing products form the very early development until routine commercial production to ensure that products comply with legal, market and customer requirements.
• You ensure that our production process is consistent with the registered and customer requirements. This includes establishment of validation plans and evaluation of validation reports in order to grant the validated status to processes or to re-evaluate existing processes in case of major process changes.
• You work together with all involved departments (R&D, Production, QC, IPC,...) to deliver in depth investigations in case of deviations and changes in the production process.
• You review, analyse and evaluate critical data in order to decide independently whether API, intermediates or final products comply with cGMP, customer and legal standards and ultimately decide about the final release for further processing or delivery to the customer.
• You develop an in depth understanding of the stakeholders needs and concerns & you develop a long term relationship with internal partners (R&D, Sales, Production, QC,...) and external partners (customers or authorities).
• You lead external project related audits: you accompany customers and authorities to make sure that they have a fair view on all process related quality documentation.

Profile

• You have a Master degree in Science or equally by experience with a good knowledge of organic and analytical chemistry & pharma regulations.
• A first professional experience in a quality or production related environment is a plus. GMP experience is a strong asset.
• You are able to oversee different processes with a helicopter view.
• You have a critical & analytical mindset. You think in a logical way to solve quality related problems.
• You are a good communicator and are able to express your arguments in a clear way. You are able to build strong relationships (internally & externally).
• You can express yourself fluently in Dutch & English (both spoken and written).
• You hold a structured work approach and are able to organize your work in an efficient way.
• You are able to work independently as together in team.
• You have an operational excellence mindset.
• You possess a good working knowledge of MS Office & Outlook. Experience with SAP & Sharepoint is a plus.