Quality Assurance - Auditor 1
Veszprem, HU
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.
Quality Assurance Auditor 1
Our company in Veszprém (Hungary) has also been operating and developing continuously for more than 30 years, which why we are looking for a new colleague:
Quality Assurance Auditor 1
Description of the position:
The job of a "Quality assurance auditor" is significantly different from what is usual in industry or production, as they require much more complex and interesting tasks, because if you have a degree in any field of life sciences, you can get acquainted with the type of studies that suit your interests in your work.
Responsibilities:
• Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, Standard Operating Procedures (SOPs) and study plans and their amendments.
• Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
• Participate in the preparation and review of study and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained. May participate in the hosting of client site visits and support regulatory inspections.
• Participate in the development of corrective and preventative actions to respond to client visit and regulatory inspection findings.
• Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
• Assist in scheduling and tracking QA audits, inspections and procedures as requested.
Key Required Skills and Education:
• Bachelor’s degree (B.A./B.S.) or higher, preferably in a life science or related discipline.
• Good verbal and written communication skills
• High degree of self-motivation with effective organizational and time management skills
• Spoken and written communication in English ang Hungarian
• Computer skills including Word, Excel
Experience required:
o 1-2 years professional experience preferred
o previous work experience with animals and/or laboratory preferred
Job location:
Veszprém
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to fostering a sense of belonging and work daily in this direction.
Job Segment:
Quality Assurance, Pharmaceutical, Laboratory, Biology, Biotech, Technology, Science