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Job DescriptionQuality Operations CoordinatorOBJECTIVES/PURPOSE:Verifies and ensures compliance with GxP and site procedures, defining and maintaining collaboration between Quality and Production.
Verifies and ensures product quality in accordance with regulatory requirements and standard operating procedures.
Promotes and disseminates quality principles within the Production department. ACCOUNTABILITIES: Review and ensure the execution of quality batch record review in compliance with SOPs and regulations.
Open and manage events identified during batch record review and/or reported by production operators.
Review production procedures and master batch record.
Identify improvement opportunities and implement appropriate CAPA to increase GMP compliance in production areas.
Actively collaborate with Production to identify and resolve compliance gaps, both documentation-related and on the shop floor.
Lead/execute development projects aimed at deepening knowledge of production activities.
Ensure GMP documentation management, including archiving, data collection, and document destruction.
Prepare equipment cleaning samples.
Verify the compliance of plasma receipt requirements. CORE ELEMENTS RELATED TO THIS ROLE:What differentiates this role and represents its core elements is Quality Oversight:ensuring batch record review, data integrity of production systems, and the management of events, changes, and CAPAs;collaborating with Production to resolve compliance gaps and ensure traceability and control of GMP documentation. DIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and
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