UK ~ Reading
Our growing and successful business comprises of over 700 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 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 systems for analytical testing and IMP manufacture.
Tasks and Responsibilities:
- Writing, reviewing and approving SOPs
- Review and approval of analytical and manufacturing documentation prior to QP certification
- Review of analytical protocols, results and investigations, ensuring data integrity
- Performing audits to monitor compliance of internal operations with internal procedures and regulatory requirements
- Participation in the change control process to ensure changes to processes, systems, equipment and facilities are appropriately assessed and implemented
- Involvement in co-ordinating sponsor GMP audits, co-ordination of responses and follow up of corrective and preventative actions
- Involvement in quality issue investigations and agreeing CAPAs
- 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
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 an analytical background
- Experience of working within a GMP environment
- Experience of auditing to GMP standards
- Science based degree preferred but willing to consider other equivalent training or vocational experience
- Good Computer literacy, high attention to detail and accuracy
- Some 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.