Senior Quality Assurance Officer

CK Group are recruiting for a Senior Quality Assurance Officer on behalf of a growing Cell Therapy CDMO, to be based at their site in Cambridge, on a permanent basis.
About the Company:
Our client is based in state of the art facilities for multi-product GMP manufacturing. Their facilities include GMP research lab space and process development suites, GMP manufacturing suites, QC lab space and cryogenic storage.
Location:
Based to the south of Cambridge, the site is located with excellent access to major road networks including the M11. Two train stations are accessible within a short distance to site.
Job Summary:
You will responsible for ensuring compliance with relevant regulatory requirements and quality standards throughout product development, manufacturing, and distribution processes. You will take lead on developing and implementing Quality Assurance systems and overseeing the management of quality records (change controls, non-conformances deviations).
About the role:
As a Senior QA Officer will work closely with multiple teams across the business to drive continuous improvement, ensuring all records are completed, monitored and reviewed in a timely manner.
Other responsibilities include:

• Provide support to the QA Manager to ensure that any quality record is assigned to a QA representative, and that stages are completed in a timely manner
• Manage and supervise a team of Quality Assurance professionals
• Participate in risk assessments and develop strategist for risk mitigation
• Identify areas for improvement and implement effective quality control measures
• Ensure effective communication with all stakeholders.

Desirable experience/qualifications:

• BSc or MSc in a life science subject or comparable experience
• Significant experience of working in Quality Assurance within the pharmaceutical or biotechnology industry, in a GMP compliant environment
• Experience of performing external and internal audits
• Strong communication skills, attention to detail and the ability to work collaboratively with cross functional teams
• Comprehensive knowledge of regulations and quality standards relating to ATMPs

To Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56510 in all correspondence.