Job Description Quality Systems Lead
* Ongoing development of the Quality systems to ensure they meet current legislation, industry standards, and customer requirements.
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* SUPPORT THE QSHE LEAD IN CONTINUOUS IMPROVEMENT OF THE OVERALL COMPANY'S QUALITY MANAGEMENT SYSTEM.
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* Lead and manage the operational performance of the Quality systems while ensuring the successful delivery of business objectives.
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* Ongoing Development and tracking of agreed Quality KPIs and coordinating the monthly review process.
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* OWN THE INSPECTION READINESS PROGRAM AND HOSTING ALL REGULATORY, CUSTOMER, AND CERTIFICATION AUDITS AND INSPECTIONS.
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* Management of supplier and raw material approval protocol ensuring all suppliers approved with specifications in place pre-purchase.
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* Manage incoming material inspection and release.
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* FACILITATE REVIEW AND APPROVAL OF CHANGE CONTROL AND DEVIATION RECORDS.
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* Product Recall process improvement and lead the mock recall process annually.
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* Management of the overall CAPA program, ensuring corrective and preventative measures taken when deviations noted.
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* Development and implementation of the Annual Business Quality Review program.
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* LEAD THE CUSTOMER COMPLAINTS MANAGEMENT PROCESS.
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* Lead the supplier non-conformances with corrective action and preventative measures.
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* Maintain competent authority authorisations, including submission of variations.
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* Communicate routinely with key stakeholders all aspects of quality activities.
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* Ensure all Quality Assurance activities support routine production needs working closely with the Quality Control lead/designate.
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* Complete validation and qualification activities as required, providing expert guidance.
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* MANAGE THE INTERNAL AUDIT PROGRAM.
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* CARRY OUT QUALITY ASSURANCE REVIEW OF BOTH BATCH DOCUMENTS AND QUALITY CONTROL/MICROBIOLOGICAL DATA TO SUPPORT BATCH RELEASE.
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* Continuously review and improve the process for batch release while ensuring batch release is within the service level agreement.
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* SUPPORT THE REVIEW OF IT QUALITY SYSTEM SELECTION AND LEAD THE IMPLEMENTATION PLAN.
REQUIREMENTS FOR THIS JOB INCLUDE:
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* Bachelor's Degree in a technical discipline to include Science, Quality or Engineering.
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* Masters degree a plus.
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* Minimum 10+ years experience in a Quality leadership role, with at least 5 years in process-based manufacturing for the food and/or pharmaceutical industry.
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* Proven record in developing and implementing successful Quality systems and procedures.
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* Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven.
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* Excellent computer skills, experience with MS Office, ERP systems, IT Quality system software etc.
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* Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, as well as executive management.
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* Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail.
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* Excellent Working knowledge of ISO 9001, FSSC22000 and HACCP standards