For a big Biopharmaceutical organization specializing in cell therapy to treat and potentially cure cancer I am looking for a QA specialist. Because of constant growth, expansion of the QA team is currently needed. One of the focus points is assess and approving any changes to apheresis process. Next to that, it also involves other activities like assuring validated state of the systems is maintained.
Assist with document change requests, change control, deviation and CAPA systems.
Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
Assist in the management of an apheresis and treatment center (ATC) qualification process that will use risk-based tools for qualification, training, monitoring and disqualification.
Collaborate with our Commercial operations in the routine management of the ATC relationships and monitoring processes.
Activation of qualified ATC in the company system.
Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards.
Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
Good knowledge of GMP, SOPs and quality system processes.
Excellent organizational skills and ability to review and update processes or procedures
Good interpersonal, verbal and written communication skills in English
ORGANISATION & OFFER You will work in a fast-growing organization that is constantly changing environment, where you make discoveries that include your own capabilities and your individual potential. This unique opportunity to make a fast development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer. The company offers the possibility to grow within the organization and it is possible to follow training courses. You can expect a competitive offer including a competitive salary and attractive conditions. INTERESTED? Reach out to Lieke Land for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org