Job Description Quality Systems Lead
Key Responsibilities of this role include:
* Responsible for ongoing development of the Quality systems.
* Support the QSHE lead in the continuous improvement of the overall companies Quality Management system.
* Ensuring the Quality Systems meet current legislation, industry standards and customer requirements.
* Lead and manage the operational performance of the Quality systems while ensuring the successful delivery of business objectives.
* Ongoing Development and tracking of agreed Quality KPIs and co-ordinating the monthly review process.
* Own the inspection readiness program and hosting all regulatory, customer and certification audits and inspections.
* Management of supplier and raw material approval protocol ensuring all suppliers approved with specifications in place pre-purchase. Manage incoming material inspection and release.
* Facilitate review and approval of change control and deviation records.
* Product Recall process improvement and lead the mock recall process annually.
* Management of the overall CAPA program, ensuring corrective and preventative measures taken when deviations noted.
* Development and implementation of the Annual Business Quality Review program
* Lead the customer complaints management process.
* Lead the supplier non-conformances with corrective action and preventative measures.
* Maintain competent authority authorisations, including submission of variations.
* Communicate routinely with key stakeholders all aspects of quality activities.
* Ensure all Quality Assurance activities support routine production needs working closely with the Quality Control lead/designate.
* Complete validation and qualification activities as required, providing expert guidance.
* Manage the internal audit program.
* Carry out Quality Assurance review of both batch documents and Quality Control/Microbiological data to support batch release.
* Continuously review and improve the process for batch release while ensuring batch release is within the service level agreement.
* Support the review of IT Quality System selection and lead the implementation plan.
Requirements for this job include:
* Bachelor`s Degree in a technical discipline to include Science, Quality or Engineering. Master`s degree a plus.
* 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.
* Proven record in developing and implementing successful Quality systems and procedures.
* Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven.
* Excellent computer skills, experience with MS Office, ERP systems, IT Quality system software etc.
* Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, as well as executive management.
* 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.
* Excellent Working knowledge of ISO 9001, FSSC22000 and HACCP standards
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