UK ~ Nottingham
GCP QA Associate
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
This is a great opportunity to join our GCP Quality Assurance team as GCP QA Associate. Your role will be to ensure that all operations related to our clinical trials are compliant with internal procedures and regulatory requirements. You will also support in the provision and development of the Quality Management System.
This role requires you to work effectively with colleagues across all functional areas to achieve objectives whilst maintaining good working relationships. You will be required to give information in a clear, concise and timely manner and often use negotiation and consultation skills to resolve complex issues.
Tasks and Responsibilities:
- Performing internal audits to monitor compliance with the QMS and with Good Clinical Practice (GCP)
- Assessment of external suppliers and subcontractors via audit or questionnaire
- Co-ordination, guidance and review of quality issue investigations and CAPAs
- Involvement in regulatory inspections as required
- Writing, reviewing and approving SOPs
- Participation in the change control process to ensure changes to processes and systems are managed appropriately to maintain GCP compliance
- Hosting customer audits of Quotient
- Delivering training programmes in Quality and GCP principles
- Maintenance and improvement of the company quality system as required
The successful candidate will have a Life Science degree and a minimum of 2 years quality assurance experience within a Good Clinical Practice (GCP).
Due to the nature of the business this role involves a high concentration of work, so the ability to work to strict and tight deadlines, whilst juggling a range of tasks/ issues simultaneously is essential.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.