Senior Quality Assurance Specialist

7 days ago

Cambridge, United Kingdom CK Group Full time

We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join a Quality Assurance team.​

​

Company Information:​

Our client is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. They provide leading support the development of complex, breakthrough therapies for a globally diverse market and are at the forefront of revolutionary medicine in which life-threatening diseases are treated.


Job Summary:​

The Senior QA Officer, will be responsible for overseeing and ensuring compliance with relevant regulatory requirements and quality standards throughout the development, manufacturing, and distribution processes of our advanced therapy medicinal products. ​

This role will take the lead on developing and implementing quality assurance systems overseeing the management of quality records (change controls, non-conformances deviations), including PQS wording. The Senior QA officer will work closely with cross functional teams to drive continuous improvement, ensuring all records are completed, monitored and reviewed in a timely manner. ​


Key responsibilities will include:​

  • Monitor and ensure compliance with relevant regulatory frameworks (GMP, GDP).​
  • Develop and maintain quality management system documentation including policies and procedures.​
  • 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.​
  • Ensuring all our suppliers meet our Company’s high standards for quality and compliance.​
  • Leading and participating in QMS initiatives.

​​

The successful candidate will have the following 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.​


This is a fantastic opportunity to join a growing organisation. We offer an attractive base salary and benefits package.


Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 101925 in all correspondence.

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