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