Senior Quality Officer

  • Oss, NL
  • 2 months ago

About Ardena

Ardena is a reputed contract partner providing drug substance and drug product development, manufacturing, logistics and bioanalytical services to pharmaceutical customers globally. In parallel, we compile the regulatory dossier for our customers to fast track their product towards compliance. Ardena has a niche expertise in development and manufacture of nanomedicines and nanocrystalline products. Every day, we guide companies through the hurdles and challenges of drug development. Our integrated service offering helps to streamline the drug’s progress to clinic and beyond, to reduce risk and timelines, and to facilitate a seamless flow of information.

We have a dedicated team with over 200 professionals divided over 6 sites in Belgium (Gent) and The Netherlands (Amsterdam, Oss, Assen), Sweden (Sodertalje), and Latvia (Riga). Ardena has an open culture. Team-spirit and entrepreneurship are important values in our company.

As a dynamic CDMO, we offer exciting career opportunities for skilled and motivated people that want to work in a fast-growing business, in the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to make new drugs a reality? Are you able to handle complex projects? Ardena offers ample opportunities to develop your scientific and technical skills as well as your managerial and commercial skills. The products that Ardena develops for her customers are generally technically highly complex and consequently offer interesting scientific challenges for our team.

In Oss, The Netherlands, Ardena has a business unit specialized in chemical process and analytical development and cGMP manufacture of Active Pharmaceutical Ingredients (API) and nanomedicines (formerly ChemConnection).

For the Oss site we are looking for

A new member for the Quality Assurance team.

Job Description:

The Senior Quality Officer ensures that GMP manufacturing activities on the shop floor and in the analytical laboratory, are executed in accordance with cGMP requirements. He/she adheres to Quality Management System (QMS), is consistent with emerging/existing corporate & regulatory guidelines and contributes to continuous improvement through leveraging the QMS architecture, assuring product quality and safety.

The Senior Quality Officer main role will be:

  • Direct engagement with manufacturing shop floor operations and analytics, by giving GMP advice, document review and approval, deviation handling.
  • Advising, facilitating, and supporting all phases of manufacturing/analytical batch documentation development.
  • Reviewing and approving GMP documentation.
  • Handling Deviations and Change Controls.
  • Releasing or rejecting finished products based on quality review.
  • Executing and improving the QMS.
  • Evaluating the performance of the Quality Management systems by means of internal audits.
  • Initiating and supporting CAPA ’s.
  • Supporting regulatory and customer inspections.
  • Executing external QA inspections.
  • Evaluatate QA aspects of investment projects (e.g. equipment and facility-related).

Qualifications

  • At least a Bachelor’s degree, with pharmaceutical, chemical or other relevant training.
  • At least 3 years relevant experience in the pharmaceutical industry.
  • Experience with quality management systems like cGMP, ISO.
  • Experience in providing GMP trainings.
  • Pragmatic attitude.
  • Able to apply phase-appropriate GMP principles in the process development trajectory.

We offer

A challenging job in an international environment within the most innovative industry branch: the pharmaceutical industry. Ardena Oss BV has an open culture; team-spirit and entrepreneurship are important values in our company.

Do you have questions?

For questions please contact Jeroen Geeven, Director Quality Assurance

jeroen.geeven@ardena.com

+31(0)6 51699242

+31(0)412 846 078

Do you want to apply?

Your response to the vacancy, including a motivation letter and CV, can be directed to:

info.oss@ardena.com