Here at SRG, we partner with an innovative, fast growing medical technology company specialising in synthetic DNA for use in gene therapy and gene editing platforms. They are looking for a Quality Assurance Coordinator to come and support the QA teams as they build an effective Quality Management System.
As the Quality Assurance Coordinator, you will be required to achieve and maintain compliance with current Good Manufacturing Practices (cGMP) and the role will involve interaction with most of the QMS and teams across the business. Some of your main duties and responsibilities will include:
- Support key Quality elements such as deviations, document management, change control, Corrective and Preventative Actions (CAPAs), support training and training record management
- Support audits by customers and regulatory bodies as needed
- Support internal audits (self-inspections)
- Monitoring of maintenance and calibration schedules and reviewing completed records where needed
- Maintain QMS documentation, keep accurate records, follow instructions, and comply with company policies in accordance with cGMP regulations
- Support continuous improvement initiatives
- Advocate the importance of Quality and compliance and foster healthy collaborations with the Production and Quality Control Teams
As the ideal candidate, you will be educated to at least degree level in a relevant scientific/engineering discipline. You will ideally have experience GMP experience within the medical device or pharmaceutical industry within a quality assurance role. You will be able to demonstrate understanding of relevant quality management systems.
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