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.
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.
An exciting opportunity has arisen for an experienced Quality Assurance Professional to join our QA team of our Safety Assessment group in Tranent. This is an excellent opportunity if you are looking to further your career in QA.
As a QA professional you will be joining a dynamic, expanding and versatile team, one of the largest QA teams in the country, leaders in our field. You will perform a pivotal role in the development of pharmaceuticals, veterinary products & agrochemicals in the fight against infectious diseases. As a QA professional you will have an oversight of the full scientific range of work carried out by Charles River by performing independent assessments, allowing for involvement in a variety of different projects and processes.
What is the role?
- Ensure all relevant documentation is reviewed, maintained and optimised to comply with international Good Laboratory Practice (GLP) and Good Clinical Practice (both human and veterinary) regulations.
- Internal system audits and external investigative site / vendor audits
- Monitor and progress CAPAs, non-conformances and similar Quality related procedures.
- Conduct inspections of procedures across site in our laboratories and animal facilities, having a complete oversight of the range of work carried out at Charles River
- Coordinating and conducting Regulatory Training.
- You will interact with staff at all levels across the site, and at Charles River sites globally.
- You will conduct inspections of studies and processes across site in our laboratories and facilities which may include the opportunity to conduct inspections across Europe.
- Advising our scientific teams and management on all aspects of quality and compliance
Essential skills and experience:
- Significant evidence of work experience across the quality assurance function
- Understanding of GLP, GCP and other GxPs
- Process mapping and written standards development.
- Quality control methodologies, spot checks and auditing.
- Ability to apply a risk based approach to auditing.
- Experience working within a team environment under time and resource pressure.
Requirements:
- Excellent fluent spoken and written English language is essential
- University degree in life sciences or other science degree
- Experience of working in a GLP/GCP QA or Compliance role
- Excellent computer skills
- Ability to complete tasks in an accurate and timely manner
What you can expect from us:
- Professional training and development support
- Benefits package, including competitive salary, pension scheme, private healthcare, employee discount scheme and volunteer opportunities
Salary for this position is £30,471.56 per annum.
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.