Concept Life Sciences is a knowledge based, science led business focused on delivering the expertise and capabilities our clients demand. We work in the pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical, chemical and consumer products sectors. In order to deliver the science our clients demand, our business is focused on a number of core sectors. We support drug discovery and development in the pharmaceutical and biotechnology markets. We provide testing and specialist analytical services and consultancy to the food and environmental sectors. We provide toxicology services to the agrochemical, consumer products, chemical and pharmaceutical industries and materials chemistry services to the petrochemical industry.
The Quality Assurance Officer is an exciting opportunity for the successful candidate to further their career. The Quality Assurance Officer’s function is the independent Good Laboratory Practice (GLP) monitoring of work conducted at Concept Life Sciences. As the Bradford site conducts work to Good Manufacturing Practices Regulations (GMP) this role will have the opportunity to cross train in GMP auditing.
Main Duties to:
- Participate in reviewing Study Plans where required.
- Schedule and conduct all audits as assigned.
- Write up findings of Quality Assurance Audits and Inspections.
- Report all audit findings to management and Study Director/Principal Investigator (as applicable).
- Prepare and issue Quality Assurance Statements.
- Write and review Quality Assurance Standard Operating Procedures.
- Review Standard Operating Procedures for compliance with principles of GLP, as required.
- Prepare and conduct computer validation audits.
- Participate in scheduling and conducting external audits.
- Review forms, where required.
- Train other personnel in all aspects of Quality Assurance Systems and Procedures as required.
- Advise management of any deficiencies in Regulatory Requirements.
- Host or partake in Sponsor and Regulatory visits as appropriate.
- Liaise with site personnel to ensure a full understanding of regulatory requirements.
- Participate and perform administrative tasks as required.
- BSc in Chemistry or related subject.
- Substantial working experience of GLP auditing.
- Consideration will be given to applicants with less auditing experience who have worked in a Regulatory GLP environment.
- The GLP regulations and principles experience we are looking for in this position are UK SI 1999 No. 3106: The GLP Regulations & OECD GLP Principles.
- 37.5hrs per week – flexibility is required, some weekend work may be needed and earlier or later start and finish times may also be required.
- There may be the opportunity to work across the company’s laboratory sites.
We offer a range of learning and development opportunities depending on the role, with all employees having access to a range of internally delivered training modules as standard. In addition to a competitive salary, we offer as a minimum: Pension scheme, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, Discounted Gym membership rates and local Reward & Recognition schemes.