QA Officer - Validation
QA Officer - 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.
An opportunity has arisen for a QA Officer – Validation to ensure that Quotient Sciences remains current and compliant with regulatory expectations on computer systems and equipment validation and qualification.
- Authoring, reviewing and approving key computer system, facilities, utilities, equipment or spreadsheet validation documents
- Authoring, reviewing and approving incidents reporting as part of a validation project
- Providing technical validation support to operational colleagues
- Supporting ongoing change management of validated systems
- Supporting the maintenance of the site Validation Master Plan
- Maintenance of validation documentation (paper-based and electronic)
- Conducting periodic reviews of computerised systems
- Maintain up to date knowledge of regulations & industry best practice relating to validation in general but particularly CSV.
- Assist with internal & customer audits and regulatory inspections where required
- Support the wider team in ensuring validation projects are completed in line with Quotient procedures and regulatory requirements.
- To comply & adhere to GXP guidelines and regulations as required of this role.
- Ensure that validation procedures are harmonised with global Quotient requirements.
- Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role.
- Perform other duties as reasonably assigned
The successful candidate will have:
- A Life Science degree and a minimum of 2 years validation experience relating to facilities, utilities, equipment & computerised systems within a GxP environment (Good Laboratory Practice (GLP), Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP)). Relevant quality assurance or IT experience will also be considered.
- Excellent communication skills including the ability to effectively communicate across organisational levels and functions.
- Competent in the use of Microsoft Office packages including Word, Excel...etc.
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 business 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 & inclusions 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.