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Just Life Sciences
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Cardiff, South Glamorgan
Senior Quality Assurance
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Salary: Up to £28,000 per annum plus benefits bonus |
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Overview
Just Life Sciences are working with a Global Healthcare Business, who through internal promotion are seeking a Senior Quality Assurance Officer on a permanent basis Specific Job Responsibilities: · To ensure that all work carried out is in compliance with company, cGMP, cGLP's, SOP's, regulatory, H&S and environmental requirements. · To provide support for Quality Incident root cause analysis, risk assessments and approval as required. · Handling customer questionnaires and complaints from receipt, through to investigation and reply to the customer. · Handling and approval of deviations and CAPAs. · Review and approval of change controls and related documentation for compliance with regulatory and GMP requirements. · To conduct internal audits and participation in the external audit programme. · To support Regulatory and Customer Audits. · To support the Technical Manager in the approval of suppliers and starting materials. · To participate in continuous improvement activities concerning the Quality Management System including preparation, issuing and distribution of SOPs. · Any other reasonable duties as identified by management. Relevant Skills, Education and Experience: Essential: · Sound written and verbal communication skills · Decisive thinker able to work within agreed timescales · Degree Qualification in a Science Discipline. · Technical report writing skills · Excellent computer skills, experience with Microsoft office essential · Excellent planning and organisational skills to ensure workload prioritisation and schedule adherence Desirable: · Knowledge of BRC, MHRA FDA Guidelines · Knowledge and understanding of interpretation of cGMPs and regulatory requirements, experience of regulatory inspections and customer audits. · Auditing skills and / or lead auditor trained. · Experience of QC/QA related activities within a food or pharmaceutical manufacturing business If you have the experience or are looking for your next position please email your CV through to justyn at justlifesciences dot com