The companyOur client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Holland Netherlands. They are a global company and leader in engineered T cell therapy.
Role descriptionYou will work within the Quality team, supporting the new area of cancer immunotherapy. You assist in the development, implementation and maintenance of a quality system. With this you contribute to the commercial marketing of the cell therapy product in the EU.
Responsibilities- Receipt and disposition of incoming materials
- Batch documentation, release and batch record review
- Preparations for product disposition by QP
- Supervise the EU packaging and shipping process and monitor the product disposal
- Review and approval of deviations, Change Controls and CAPAs
- Handling of product complaints for EU
- Liaise with other manufacturing sites, supply chain, CMO’s, corporate quality and other quality groups to maintain global quality
- Implement and maintain GMP training system in EU
- Support and manage the inspection process
Requirements- BSc or MSc in biological sciences or related field
- 5+ years of quality or manufacturing experience in a Pharmaceutical, Biotech or Biologics organization
- Working knowledge and ability to apply GMPs in conformance to US and EU standards
- Excellent written and spoken English language skills (Dutch is a plus)
- Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
- Excellent MS Office skills
- Experience with and knowledge of Change Control practices, Deviations and CAPA, manufacturing processes, GMP, including GDP, SOPs and quality systems
Other informationOur client is looking for someone who can start as soon as possible. This person needs to be an all-rounder and selfstarter who can operate without guidance and is able to work in a dynamic and diverse team.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.