| London Jobs |
| Manchester Jobs |
| Liverpool Jobs |
| Nottingham Jobs |
| Birmingham Jobs |
| Cambridge Jobs |
| Glasgow Jobs |
| Bristol Jobs |
| Wales Jobs |
| London Jobs |
| Manchester Jobs |
| Liverpool Jobs |
| Nottingham Jobs |
| Birmingham Jobs |
| Cambridge Jobs |
| Glasgow Jobs |
| Bristol Jobs |
| Wales Jobs |
| Oil & Gas Jobs |
| Banking Jobs |
| Construction Jobs |
| Top Management Jobs |
| IT - Software Jobs |
| Medical Healthcare Jobs |
| Purchase / Logistics Jobs |
| Sales |
| Ajax Jobs |
| Designing Jobs |
| ASP .NET Jobs |
| Java Jobs |
| MySQL Jobs |
| Sap hr Jobs |
| Software Testing Jobs |
| Html Jobs |
| Job Location | Cambridge |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
CK Group are recruiting for a QA Assistant 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, They are currently undergoing an extensive period of growth and development, and are expanding the QA team as part of this growth. They have an established eQMS and LIMSsystem, and their facilities include GMP research lab space and process development suites, GMP manufacturing suites, QC lab space and cryogenic storage.They are within easy commuting distance from Cambridge City Centre, and with excellent transport links to Central London.About the Role:Working within the Quality Assurance (QA) team, reporting to the Head of QA, the main purpose of this position is to establish a quality framework for effective use in manufacture of cellular therapies. You will contribute to promoting a culture of regulatorycompliance, continuous Improvement and safety awareness in a risk-based Quality Management System (QMS), liaising with staff across the various departments within the company.You will support the QA team to oversee risk assessments and Change Control processes and will also be responsible for documenting control processes. You will participate in preparing the site for Regulatory inspections, including MHRA and HTA, and maintenanceof regulatory standards.Your responsibilities will include:- Participation in internal and regulatory audits.- Ensuring that processes and documentation are GMP compliant for products falling under the MHRAs specials and MIA (IMP) licence. - Acting as scribe in regulatory audits, as required.- Control of documents; maintenance of records and use of Q-Pulse for document control and other elements of the QMS including DocuSign.- Providing support with administration of the eQMS, Q-Pulse, including non-conformance, root cause analysis and CAPAs.- Providing support for supplier qualification, user requirement specifications, evaluations and material specifications.- Ensuring that trending and review of CAPAs, KPIs and document review tracking is carried out.About You:To be considered for this position you should have the following skills and experience:- Qualified to a minimum of BSc level (or possess equivalent experience) in a relevant Life Sciences subject.- Experience of working in a highly regulated (e.g. GMP) environment, and using a QMS.- Experience in QA would be beneficial, but is not essential as full training will be provided.Apply:For more information, or to apply for this position, please contact Sarah Farrow on or . Please quote job ref 54604 in any correspondence.