UK ~ Nottingham
QA Associate - Validation
Our growing and successful business comprises of approximately 750 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.
Due to business growth, Quotient’s Quality Assurance department have a brand new, exciting career opportunity for a QA Associate – Validation. The QA Associate – Validation will ensure that all operations related to Computer System Validation 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.
Main tasks and Responsibilities:
- Authoring, reviewing and approving key computer system validation documents
- Authoring, reviewing and approving incidents reporting as part of a validation project
- Providing technical validation support to operational colleagues
- Maintenance of validation documentation (paper-based and electronic)
- Conducting periodic reviews of computerised systems
The successful candidate will have a Life Science degree and a minimum of 2 years CSV (Computer System Validation), quality assurance or IT experience within a Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP) environment.
The successful candidate will possess excellent communication skills including the ability to effectively communicate across organisational levels and functions.
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.