Validation Officer

Req ID:  191891
Location: 

Keele, GB, ST5 5SP


At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families. 

 

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. 

 

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

 

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   
 

Job Summary

Reporting to the Validation Leader, the Validation Officer is responsible for working collaboratively with Operations and with Quality Control teams to perform activities under the site Validation System ensuring that GMP compliance is maintained at all times.

Profile and Requirements

Main duties will include: 
•    To support the Validation Leader in proactively managing the site Validation System in accordance with the Site Validation Master Plan (SVMP) to defined timelines.
•    Oversee and manage on time delivery of all aspects of Validation to GMP.
•    Work closely with Operations, Quality Control and Project Management to ensure that the scheduling of Validation work supports project timelines without compromising quality and compliance.
•    Generation of a wide range of documents, including, but not limited to, Validation Plans, User Requirement Specification, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, 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 and Client audit preparedness activities and action closure.

 

You will be educated to degree level or equivalent in a science subject with demonstrable pharma experience in a validation, manufacturing or quality assurance role. You will have broad knowledge of pharmaceutical systems and/or processing equipment (eg water systems, autoclave, fermenter) in relation to operation and qualification parameters and have experience in regulatory and client audit preparedness activities and action closure.

 

You will have the ability to deliver on a wide range of programmes of work, demonstrate excellent problem-solving skills and be able to work independently to plan and prioritise your own work. You will demonstrate reliability, integrity and respect of confidentiality on work related and personal matters. In addition, you will demonstrate strong verbal and written communication skills.
 

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 
 

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 120 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 90 facilities in 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 ~85% 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.

 

For more information, please visit www.criver.com.