Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.
As a GMP Specialist you will be the owner of GMP related processes such as audits and inspections, the deviation and change control process, evaluations and trend reports within Operations.
- Keeping up-to-date and implementing improvements for the deviation and change control processes.
- Identifying and advising on deviations and change controls within the production process.
- Acts as SME and facilitates in complex and/or cross-departmental deviations.
- Organization of inspections within Operations and, together with QA Compliance, facilitates the staffing of the inspection teams.
- BSc or MSc degree in Biotechnology, Biochemistry, Biopharma, (Micro)Biology, Process Technology (or equivalent training).
Knowledge of cGMP requirements for both clinical and commercial manufacturing
- Experience within Quality Assurance is an advantage.
Result - and performance-oriented, flexible, critical, problem-solving and innovative thinking.
- Good communication skills in English and Dutch.
For more information please contact Guilherme Tokunaga at firstname.lastname@example.org or +31 (0) 20 658 98 01.