Our client is in the transition from an R&D focused organization to the production of innovative medicines. You enter an environment in which you can build, adapt and where you are expected to think along.
You support the quality department and interact directly with other departments on Changes, CAPA, Deviation management and documentation. As Quality Associate you will identify, defend, and resolve quality issues with appropriate supporting documentation. You are able to weigh the risk of the event and look for the efficient yet compliant solution.
- Guiding employees to GMP level and ensuring alignment and agreement on quality issues
- Review of the Batch records, related deviations, CAPAs and CRF as well as OOS and EMP investigations
- Review SOP’s, forms, and test methods within Document Management System (DMS)
- Responsibility to justify changes, procedures are followed and contain appropriate associated reference
- Review and approve non DMS documents, such as: executed work orders, Engineering Preventative Maintenance documents and Environmental Action Reports
- It is a dynamic job with a lot of challenges, in which you can further develop your talents
- You will work with smart and passionate colleagues in an innovative and growing organisation.
- You will work in an International environment with 10 different nationalities
- You play an essential role in making cell therapy available to the patient
- Life science degree Biotechnology or related discipline with focus on cell biology and/ or human cell culturing techniques
- Good understanding and working experience with GMP in a production setting.
- Working experience in Quality Assurance
- Good proficiency in English
- Good knowledge of standard MS-Office products
- Attention to detail
- Working effectively individually and with teams in which you can guide people towards a GMP working environment
- Stress-resistant regarding to dynamic environment
that operates in Oss and thinks globally.
Dynamic, Innovative and ambitious are characterizing the organization.
The activities of our client are genuinely scientifically innovative and are at the forefront of the development of new medicines.
They are ambitious, believe in their product and want to fight cancer. - this is what this company is all about.
You will be part a team of young, driven QA-professionals in a GMP environment on activities related to cell therapy and regenerative medicines. You will support your team in establishing a quality system of allogeneic cell products in accordance to GMP and applicable international guidelines.
- Competitive salary, after your first year your salary will be adjusted accordingly with your performance and dedication
- Pension premium contribution
- Travel allowance or public transport reimbursement
- Flexible working hours (presence between 9:00-15:00)
- 25 holidays
- Holiday pay
If you want more information please call, whatsapp or mail:
Ellen de Kroon, Recruitment Consultant
+31 6 53 170 757