Quality Operations Coordinator

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Quality Operations Coordinator OBJECTIVES/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 complexity of technical knowledge) Required: Degree in scientific discipline and knowledge of pharmaceutical applicable regulations, or demonstrated/approved knowledge of manufacturing processes. Good command of English. Excellent knowledge of the manufacturing process and quality principles. Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change) Be positive Be accountable Be results-oriented Good communication skills Problem-solving attitude Good teamwork skills Good knowledge of cGMP Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving) Good ability to work independently Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships) Good communication and negotiation skills Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking) Good ability to optimize workflows in classified areas Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations) Direct interface with Production, Maintenance, Calibration, and Quality personnel EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Good command of English (written and spoken) Excellent analytical and problem-solving skills Excellent communication, negotiation, and leadership skills Excellent technical writing skills and presentation skills . Locations ITA - Rieti Base Salary Range: €31,200.00 - €42,900.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. For information about our benefits, please click here . Worker Type Employee Worker Sub-Type Regular Time Type Full time