For our client, a company in Biotechnology/Pharmaceuticals, we are looking for a Senior QA Officer based in Brabant.
Our client has focus on the development of different cellular immunotherapies, which have the potential to treat various types of cancer, such as leukemia, lymphoma and solid tumor.
The Sr QA Officer will be part of young team which consist of driven QA-professionals in a GMP environment on activities related to cell therapy and regenerative medicines. Sr. QA Officer will be responsible in establishing a quality system of allogeneic cell products in accordance with GMP and applicable international guidelines.
He/she will report to the QA Manager.
- Contribute to improve the Quality System, implement and improve current procedures and processes such as the management of training, audits and vendors;
- Take the lead in QA projects such as implementation of an electronic document management system and an electronic quality management system;
- Write, implement, review and maintain procedures and other QA related documentation in alignment with applicable GxP guidelines. Identify documents which need to be created or updated and ensure this is organized;
- Interacts directly with other departments with respect to training, change control, CAPA, deviation, risk assessments audit management and documentation;
- Maintain and evaluate quality indicators;
- Be able to weigh the risk of the event and provide the most efficient compliant solution;
- Performing and reviewing internal and external audits, as lead auditor, to determine compliance with applicable guidelines (like GMP, GLP, GDP);
- Represents QA department in significant complex projects with respect to improvement/efficiency projects;
- Perform other duties as assigned;
- Perform a variety of routine work within established procedures and receive general instructions on new assignments.
- BSc /MSc. in Science, Biotechnology or related discipline with focus on cell biology and/ or human cell culturing techniques (stem cells, primary cells and/or tissue culture);
- 5 years' experience in a GMP-environment with at least 3 years' experience in Quality Assurance;
- Good understanding of GMP's, regulations, and compliance in a GMP manufacturing setting;
- Good proficiency in English;
- Good knowledge of standard MS-Office products;
- Attention to detail, works effectively individually and with teams.
What do we offer
- A permanent position in a dynamic company;
- An international environment where you can learn a lot in challenging projects;
- An attractive compensation package;
- Start date negotiable and the position can be filled for 32 - 40 hours a week.
T: 06-33 13 77 46.
When interested please react through the application process with your English resume.
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