Taken en verantwoordelijkheden

  • 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.

Profiel kandidaat

  • 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.  

Geboden wordt

  • Be part of a stable and recognised company that has the “Power to Make”.
  • An attractive salary package including fringe benefits (eg hospital insurance, pension plan, bonus plan and a great company restaurant)
  • Be part of an organisation that offers personalised technical training, personal development opportunities and prospects to internal mobility
  • A pleasant, no-nonsense, people-oriented working atmosphere with employee initiatives and events.

Meer informatie

Voor meer informatie bekijk onze bedrijfspagina (klik op ons logo bovenaan de vacature).

Solliciteer direct via onderstaande button.

Acquisitie naar aanleiding van deze vacature wordt niet op prijs gesteld.

Solliciteren kost slechts enkele minuten.

Hier ga je werken: Ajinomoto Bio-Pharma Services

Ajinomoto Bio-Pharma Services komt voort uit de integratie van de activiteiten van Ajinomoto Althea & Ajinomoto OmniChem. Sinds 2018 treedt Aji Bio-Pharma op als een volledig geïntegreerde organisatie voor contractontwikkeling en productie die streeft naar een hoog kwaliteits- en serviceniveau om aan de behoeften van onze klanten te voldoen.
Ajinomoto Bio-Pharma Services omvat de productie van ‘small molecules’, voorhee...

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