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.
This is a great opportunity to join our Quality Assurance (QA) team as a QA Associate based at our Reading site. In this role the successful candidate will need to ensure that all operations are compliant with internal procedures and regulatory requirements. You will also support in the provision and development of efficient and effective QA.
Tasks and Responsibilities:
- Writing, reviewing and approving SOPs
- Writing of Quality technical agreements
- Review and approval of project risk assessments
- Review and approval of analytical and manufacturing documentation prior to QP certification
- Participation in the change control process to ensure changes to processes, systems, equipment and facilities are appropriately assessed and implemented
- Involvement in supporting sponsor GMP audits, co-ordination of responses and follow up of corrective and preventative actions
- Involvement in quality issue investigations and agreeing CAPAs
- Support the development and implementation of the company quality system as required
- Interpretation and communication of information (e.g. GMP requirements) and provision of advice on quality issues to members of staff and clients
- Review and approval of validation activities such as equipment and computer systems validations
- Involvement in regulatory inspections and sponsor audits as required
- Review of analytical protocols, results and investigations, ensuring data integrity
- Performing audits to monitor compliance of internal operations with internal procedures and regulatory requirements
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.
- Ideally from a Pharmaceutical Quality Assurance background
- Experience of working within a GMP environment
- Science based degree preferred but willing to consider other equivalent training or vocational experience
- Good Computer literacy, high attention to detail and accuracy
- Exposure to pharmaceutical manufacturing would be an advantage.
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.