Your challenges are to participate in projects in the exciting field of cancer immunotherapy and to support the manager QA and QP in execution and development of the QA system by assessing and approving quality documentation. You have an important role in maintaining the documentation system and QA and clinical archives. Furthermore you assist in improving the compliance of ISA in relation to GMP production, release and R&D activities.
You have a BSc or MSc-degree in Biology or in a Life Sciences-related area, you have hands-on experience with QA and documentation systems, reviewing and archiving of QA documentation like change requests, deviation reports, complaints and CAPAs. Furthermore you are able to review R&D study protocols and reports as well as GMP production batch records. You are a flexible person with good communication skills, who acts as a team player and is able to work accurately and independently.
We offer you a challenging position in a rapidly developing organization. You will be part of a team of top professionals, and work in an inspiring environment with opportunities for personal and professional growth. This function can also be a parttime function.
The company culture of ISA is built on four important competences: high quality knowledge, a pragmatic & solution-oriented attitude, we are agile & resilient and appreciate collaboration & learning
Founded in 2004, ISA Pharmaceuticals is a privately held company based in Leiden, the Netherlands. With a dedicated team of 25 professionals, ISA focuses on the development of immunotherapies for the treatment of cancer and persistent viral infections. ISA’s immunotherapy platform is based on its proprietary SLP® (Synthetic Long Peptide) and AMPLIVANT® technologies. Various clinical trials up to completion of Phase II have demonstrated the safety, tolerability and clinical efficacy of SLP® immunotherapies. Because of our ongoing expansion we have the job opening for a QA Officer.
For further information on this job opening and related career opportunities, please contact Willem-Jan Krebber at email@example.com or +31 71 3322310. Acquisition based on this advertisement is not appreciated.