Jobs in Keele, eng, uk

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.

Job Summary

Working at our GMP Licenced CDMO facility in Keele, you will be collaborating with Operations, Quality Assurance and Quality Control teams to perform activities under the site Validation System ensuring that GMP compliance is maintained at all times.

• To support the Validation Leader in proactively managing the site Validation System in accordance with the Site Validation Master Plan (SVMP) to defined timelines.
• To oversee and manage on time delivery of all aspects of Validation to GMP.
• To work closely with Operations, QC, QA and Project Management to ensure that the scheduling of Validation work supports project timelines without compromising quality and compliance.
• To plan and prioritise own work.
• Generation of a wide range of documents, including, but not limited to, Validation Plans, URS, DQ, IQ, OQ, PQ, Validation Summary Reports, and maintenance of the SVMP.
• Oversight and attendance of vendor qualification as required.
• Providing ‘in suite’ execution of validation documentation supporting GMP manufacture, QC laboratories and Warehouse storage.
• Investigation and resolution of any errors identified during execution of validation documentation.
• Supporting the Validation Leader in Regulatory ad Client audit preparedness activities and action closure.
• To adhere to proper compliance with Health and Safety of all operations in accordance with Company’s Health, Safety and Environmental policies and procedures.

Job Qualifications

What We Offer You

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.