Quality Assurance Specialist

3 weeks ago

Llantrisant, United Kingdom Just Life Sciences Full time

**Just Life Sciences** are seeking a suitably qualified Quality Assurance specialist who will support the QP in execution of their legal and operational duties.

**Responsibilities**
- Administration, control and support core systems within the Pharmaceutical Quality system as allocated by line manager. Including but not limited to Internal audits, supplier management, deviations/complaints, CAPA, change control activities and documentcontrol.
- Overseeing of site licences.
- Participate in client and regulatory audits of the facility.
- Generate and approving PSF and technical documentation.
- Represent the Quality department for key client accounts, client enquiries and attending client calls.
- Support delivery of site/departmental projects and objectives.
- Support continuous improvement projects and opportunities.
- Author standard operating procedures.
- Provide QA and GMP related training
- Administration, control and support core systems within the Pharmaceutical Quality

**Other Duties**
- Schedule, host and close out client and regulatory audits.
- Pre-certification assessment of batch records and generation of draft QP certificates.
- Post QP certification batch release via the inventory system.
- Pre-approval assessment of change controls and deviations.
- Co-ordinate and perform investigations into internal and external quality issues.
- Support CAPA’s and change controls activities.
- Schedule, perform and close out internal and external audits within established timelines.
- Site metrics for systems within scope of responsibility.

**Qualifications**:

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