Quality Assurance and Quality Control Officer
2 weeks ago
The Heart Lung Centre is a specialist research unit located within the Queen Anne Street Medical Centre. The Unit is dedicated to evaluate the mechanisms of airways disease and the properties and clinical potential of new therapeutic agents in allergy, asthma and COPD. We specialise in clinical trials and drug development.
We require a QA & QC Officer to join the QA department to support the QASMC Clinical Trials, and help ensure regulatory compliance and adherence to company Policies and SOPs.
1. Provide support to the QA Manager with all QA activities.
2. Administer internal systems of Quality Assurance and Quality Control.
3. Review and perform Quality Control Checks on Controlled Documents such as Policies and SOPs and their associated forms before they are released.
4. Perform Quality Control Checks on Clinical Trials Source Documents.
6. Act as the Master Archivist for QASMC and the Clinical Research Department.
7. Manage the SOP control, administration, distribution and storing system.
8. Manage and maintain all controlled document matrixes.
9. Assist the QA Manager with the implementation of the yearly audit schedule.
10. Assist with CAPA creation, CAPA documentation and CAPA tracking.
11. Assist in the preparation for inspections carried out by Regulatory bodies (e.g., MHRA, CQC) and help host those inspections.
12. Design training materials and carry out training independently.
13. Assist in staff development by providing training and support to staff.
14. Assist in the creation of reports for KPI purposes.
15. Represent the QA Department in team meetings.
**Qualifications and Skills**
- Experience in Clinical Trials Research - Desirable
- Good report, SOP and Policy writing skills
- Experience in Clinical Trials monitoring - Desirable
**Benefits**
- 25 Days Holiday per Annum, plus UK Public Holidays
- Day Off for Your Birthday
- A Contributory Pension Scheme
- Private Healthcare Scheme
**Job Types**: Full-time, Permanent
**Job Types**: Full-time, Permanent
**Salary**: £24,000.00-£27,000.00 per year
Schedule:
- 8 hour shift
Work Location: One location
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