Are you the ambitious, energetic, proactive, reliable and flexible professional with humor to support an international biotech company as senior QA officer? Then we are looking for you!
For our client, an international company in Biotechnology/Pharmaceuticals, we are looking for a Senior QA Officer based in Brabant.
Our client has focus on research, development and manufacturing of different unique cellular immunotherapy therapies, which have the potential to treat various types of cancer, such as leukemia, lymphoma and solid tumor. Their mission is to cure cancer.
The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role.
The Sr QA Officer will be part of a young team which consists of driven QA-professionals in a GMP environment on activities related to cell therapy and regenerative medicines.
In this role he/she will be responsible to ensure the quality cell therapy products to support product disposition, together with the Qualified Person, intended for clinical studies. Next to this the Sr QA Officer will support the management and improvement of Glycostem quality systems.
The Sr Quality Officer will work closely together with Development, Operations and Quality Control departments.
The goals of the QA department: responsible for quality assurance at any GXP stage of testing, manufacturing, distribution or other operational processes, relating to approval of specifications, test methods, procedures, suppliers, contract companies, manufacturing instructions and validation documentation, review and approval of manufacturing documentation, testing and validation activities, release of products and ensuring quality systems procedures for products or services.
- Review of batch manufacturing records and associated deviations, change controls;
- Review of media simulations and environmental monitoring data;
- Compile product release packages to support product disposition by the QP;
- Contribute to manage and improve the Quality System, implement and improve current procedures and processes such as the management of change notifications, internal and external audits and vendorsl;
- Write, implement, review and maintain procedures and other QA related documentation in alignment with applicable GxP guidelines;
- Interacts directly with other departments with respect to training, change control, CAPA, deviation, risk assessments audit management and documentation;
- Maintain and evaluate quality indicators together with stakeholders such as manufacturing and warehous;
- 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 (CMC projects) with respect to e.g. manufacturing improvements/efficiency projects.
- BSc /MSc. in Science, Biotechnology or related discipline with focus on cell biology or human cell culturing techniques (stem cells, primary cells and/or tissue culture);
- 5 years' work experience within a GMP environment in a biopharmaceutical or cell therapy company 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
- 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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