Glycostem is looking for an ambitious, energetic, proactive, reliable and flexible professional to support us as senior QA associate, quality systems.
We develop an innovative therapy to make cancer a chronic disease and can use some help. We are a Dutch, globally thinking company that operates in Oss, with inhouse research, development, manufacturing and quality control activities. We are ambitious, believe in our product and want to fight cancer - this is what Glycostem is all about.
Full time position
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 young team which consist of driven QA-professionals in a GMP environment on activities related to cell therapy and regenerative medicines. You will be responsible in establishing a quality system of allogeneic cell products in accordance with GMP and applicable international guidelines.
Main responsibilities of the QA associate
• 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.
In this role you must likewise perform a variety of routine work within established procedures and receive general instructions on new assignments.
Education, skills and experience
The job as QA Associate Quality Systems will be held by a person with:
• 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
• Good proficiency in English
• Good knowledge of standard MS-Office products
• Attention to detail, works effectively individually and with teams.
Duration of employment:
After a successful probation period a permanent contract is extended.
Do you have what it takes?
Please convince us by sending your motivation and CV in English to Liana van Genuchten (HR@Glycostem.com). Selected candidates will be invited for a face-to-face interview with the line management.
Want to know more?
E-mail our HR department at HR@Glycostem.com for more information about Glycostem and the selection process.
Recruiters should not contact us.
Please be aware that your application means that the information you provide will be shared by and with HR and the employees who are involved with the procedure. In case the procedure with you ends, your application and provided information will be deleted within four weeks after the moment you have been informed. Your name and date of application will be registered in our database for statistical use and status only. By applying you agree with and have taken notice of these conditions.