Thank you for your interest. Due to our collective summer closure, applications will only be processed again starting August 10
- 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.
