This role will report to the facility Quality Manager is responsible to provide leadership and direction for cGMP and food safety & quality engineering to the Maintenance, Engineering, and Operations Departments. You will oversee the food safety plan, HACCP to HARPC transition, and assure the facility meets FSMA Section 103 Preventive Controls and Supplier Controls regulatory requirements. You are the lead site quality and food safety risk assessments and management programs. You will improve and implement projects to mitigate and address potential quality and food safety risks for the site. You will support for areas such as CAPA/Nonconformance Investigations, Customer Complaints, and Audits and leads validation of corrective actions that meet CAPA closed-loop regulatory requirements of FDA registered food or pharmaceutical manufacturing facilities. Leads the plant Food Safety Management System in a manner that will ensure compliance with a regulatory, quality system, and customer requirements. This includes a thorough evaluation of building infrastructure and expansion or upgrading facilities and food contact equipment to assure that quality and food safety are built into all new/upgraded equipment or structures. Supports the facility Quality Manager in continuous improvement activities of the Quality and Food Safety Management System. Serves as food safety project lead, ensuring cGMPs are adhered to during design & commissioning. Leads all product adulteration incident reviews and provides leadership in microbiological management and sanitation excellence. Capable of influencing people while managing issues with a wide variety of internal and external partners. Validates systems for food safety control points per HACCP/HARPC plans.
Responsibilities
Required Experience
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