QA Associate – Validation
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Due to business growth, Quotient’s Quality Assurance department have 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.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.