We are SIMABS
SIMABS is a biotechnology venture that provides cost-effective therapeutic monoclonal antibodies to biopharmaceutical companies.
Our mission is to set the new standard in biopharmaceutical manufacturing technology. Our values are simple: we strive to KISS, Innovate, and Enjoy the flow.
Job Content:
As our QA Manager, you will combine project QA tasks with routine QA tasks and maintenance of the Quality Management System (QMS) within the company.
Responsibilities:
* Project QA
o Support implementation of new products at our GMP site
o Discuss and review tech transfer data packages and implementation documents
o Write and review project-specific validation protocols & reports
* Routine QA
o Issue master batch records and conduct batch record review
o Support and review of Environmental monitoring activities
o Release incoming materials and write material specifications
o Assist in supplier qualification and requalification
o Ensure QA oversight on Good Documentation Practices and Good Manufacturing Practices
* Maintain the Quality Management System
o Review & follow-up of events, planned deviations, supplier complaints, OOS, CAPA, and change requests
o Write and review SOPs, work instructions, and forms
o Archive records and files
o Prepare management review documentation
o You work closely together with the head of quality
* You engage in a broad range of activities to grow simAbs into a strong and reliable partner for future clients.
Education:
A Master's Degree in Biochemistry, Chemistry, Pharmaceutical Lab Technology or equivalent through relevant experience is required. 5-10 years of working experience in a GMP environment is ideal.
Competences:
Technical Skills:
Skilled in GMP and Good Documentation Practices
Soft Skills:
Quality-minded, high degree of accuracy, well organized, result-oriented team player, fast assembly of new information, swift learning on the job, strong and honest communicator, flexible, good Dutch knowledge, and an enjoyment of the start-up flow of our organization.