Qualified Person

Req ID #:  162175
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

 

We are currently looking to recruit a Qualified Person (QP) to join our team in Keele, Staffordshire. The QP will report to the Quality Director and will be accountable for review of relevant documentation associated with the manufacture and testing of Biopharmaceutical Starting Materials and Bulk Drug Substance intermediates.

The QP will be responsible for ensuring the timely disposition of GMP batches and acting as a GMP Subject Matter Expert (SME) to facilitate site compliance with the Company’s Pharmaceutical Quality System (PQS).

•    To be named on the Keele Manufacturing Licence(s) and have responsibility for ensuring that the respective regulatory requirements for batch release are met.
•    Perform QP duties in accordance with Directives 2001/83/EC, 2003/94/EC, 2001/20/EC, and Eudralex Volume 4, part I, II and III including relevant annexes.
•    Support internal and external queries relating to QP responsibilities and batch disposition.
•    To ensure that continual professional development (CPD) is maintained.
•    Apply GMP regulations consistently, using quality and compliance knowledge base to mentor other on-site staff to expand on-site compliance knowledge, to support staff in providing timely responses to Customer queries and communications relating to GMP compliance and batch release.
•    Utilise knowledge of GMP and quality processes to actively identify, suggest, and participate in site continuous improvement activities. 
•    Provide quality assurance support to initiate, manage and escalate major and critical compliance issues through the site QMS processes, e.g. Deviations and CAPA.
•    To support on time delivery of Quality contract deliverables.
•    Ensure there is representation in internal meetings where QP input is required (eg commercial proposals and client meetings)

Job Qualifications

 

You will be educated to degree level or equivalent in Chemistry, Biology or Pharmacy and have extensive experience as a QP within a Biopharmaceutical manufacturing environment, covering both IMP and Commercial product release. QP eligibility and associated membership of the Royal Society of Chemistry, the Institute of Biology or the Royal Pharmaceutical Society is essential. External Lead Auditor status would be advantageous but not essential. 

You will have demonstrable experience of developing, mentoring, training and enforcing a site Quality culture, in addition to supporting senior Quality and Operations leaders with GMP compliance and batch release decision-making. Strong written and verbal communication skills are therefore essential.

In addition, knowledge or experience of computerised system validation and/or experience in the implementation and evolution of electronic Business Management Systems would also be beneficial.

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 Corporate Functions
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.  

 

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 17,000 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. And in 2019, revenue increased to $2.62 billion.
 

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 2019.
 

Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
 

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


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