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Job Location | Llantrisant, Pontyclun |
Education | Not Mentioned |
Salary | Salary negotiable |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , 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 QualityOther 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 CAPAs 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:HNC, HND or degree (or equivalent) in a life sciences subject or suitable experience in a Quality Assurance or technical role within the pharmaceutical industry
Keyskills :
GMPPharmaceuticalBatch Release