Quality System Auditor
Den Bosch (S-Hertogenbosch), NL, 5231 DD
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Are you currently working as a laboratory technician or e.g. study director in our GLP facility and do you want to pursue a different career path?
Quality Assurance System Auditor
Department:
Our Quality Assurance team consists of about 21 staff members. Besides having quality of data as top priority all our auditors have a scientific background in the various disciplines ranging from chemistry and (environmental/genetic) toxicology to in vitro and in vivo metabolism.
With the team we safeguard the adherence to GLP standards of study data by, among other things, conducting process- and facility inspections, and audits on critical in-life study phases its data and reporting. The versatility of our work continues to support by also providing up to date GLP training on an operational level, being available to tackle any GLP related questions and partake in hosting audits from clients and regulatory visits.
About your role:
As one of the Quality Assurance System Auditors, you obtain a critical position within the Quality Assurance department, essential for maintaining the company’s reputation for quality and compliance. This role not only ensures adherence to GLP standards but also plays a pivotal part in client retention by providing the necessary support during their visits.
In your role as a system auditor, you will be liaising with our clients to ensure that each client's specific needs regarding GLP compliance are met, fostering trust and satisfaction. Moreover, by overseeing internal facility inspections, supporting regulatory/monitoring authority inspections, and providing GLP training the QA System Auditor helps safeguard the company against potential compliance risks, protecting both its operational integrity and its standing with regulatory bodies.
Primary responsibilities:
• Perform and/or oversee internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems;
• Oversee internal process audits at planned intervals to evaluate effective control and maintenance of site quality systems;
• Perform and/or oversee vendor audits at planned intervals to evaluate effective control and maintenance of site quality systems;
• Perform auditing of simple validation packages;
• Oversee and/or participate in the facilitation of site GLP training program;
• Host and/or oversee all aspects of QA client visits;
• Host and/or oversee all aspects of regulatory/monitoring authority inspections;
• Provide recommendations for improvements in auditing of quality systems based on knowledge and understanding of regulations and quality principles.
What is required:
• Bachelor's degree in life science and/or experience with GLP or a comparable quality system;
• Understanding of relevant quality systems; in this role you need to be very precise and quality focused;
• Approachable and client-orientated;
• An excellent proficiency of the Dutch and English language;
• Residential in the Netherlands;
• Good communications and advisory skills;
• Work as a team member;
• Accurate and quality minded;
• Critical but positive;
• Quickly in learning software programs.
About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 350 patents and 80 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.
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