QA Officer

2 months ago

Cambridge, United Kingdom CK GROUP Full time

CK Group are recruiting for a QA 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, 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 contribute to 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 MHRA’s specials and MIA (IMP) licence.
- 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.
- Participate in 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:

- Experience of working in a highly regulated (e.g. GMP) Pharmaceutical or Biotech manufacturing environment, and using a QMS.
- Experience in QA with relation to Pharmaceuticals or Biotech is Essential.

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54605 in all correspondence.

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