OVERALL ROLE OJBECTIVE:
The position will have responsibility for ensuring procedures are adhered to and EU GMP regulation compliance is maintained upon completion of documentation, by performing quality assurance review of completed documentation, or review of new and updated SOPs/policies. The successful candidate will also be responsible for document control functions, when required, such as issuance of documentation and GMP compliance reviews
The QA Analyst will join TC BioPharm Ltd (TCB), an established, fast growing and ambitious cancer immunotherapy company developing cell-based treatments for cancer and severe viral infections. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report to the QA Department.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Quality review of documentation such as workbooks, forms and other documentation contained within batch manufacturing records, Quality management system (QMS) records such as corrective and preventative actions (CAPA), change control etc.
- To assist the Quality department in the overall implementation of the Quality function necessary for the maintenance of the quality management systems and related activities.
- Provide general support to all Quality Unit activities relating to GMP, GCP, and non-GMP.
- Follow-up on corrective and preventative actions to ensure a timely close out of actions.
- To identify and contribute to areas for improvement within the quality management systems to ensure compliant and efficient systems.
- When required, aid in document control functions, such as issuance of SOPs, policies, qualification documentation, and issuance of forms or workbooks for use in GMP and Non-GMP areas.
THE CANDIDATE:
- Minimum 2 years’ QA experience in a GMP environment
- Demonstrable experience and sound knowledge of GMP regulations
- Excellent Microsoft Office skills.
- Good organisational skills with a high level of accuracy and attention to detail
- Ability to work independently and as part of a team
- Competence in both written and verbal communication.
- Ability to interact with personnel at all levels from a variety of disciplines.
If you are looking to work within a challenging, dynamic, and rewarding environment, then TCB represents an excellent career move. This is an opportunity to be part of an established, fast-growing, ambitious business where people development is critical to future success. As we continue to expand, there will be career opportunities on a truly global scale.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary (reviewed annually), we offer a comprehensive range of benefits and an excellent working environment.
Holiday Allowance: 32 days paid holiday p.a. Benefits include pension and free car parking
Hours: 37.5 per week Monday to Friday, normal office hours apply