12 ott - Rieti
Takeda
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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 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 positiveBe accountableBe results-orientedGood communication skillsProblem-solving attitudeGood teamwork skillsGood knowledge of cGMPDecision-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 independentlyInteraction(The span and nature of one's engagement with others when performing one's job, internal and external relationships)Good communication and negotiation skillsInnovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)Good ability to optimize workflows in classified areasComplexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)Direct interface with Production, Maintenance, Calibration, and Quality personnelEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Good command of English (written and spoken)Excellent analytical and problem-solving skillsExcellent communication, negotiation, and leadership skillsExcellent technical writing skills and presentation skills. LocationsITA - RietiBase Salary Range:31,200.00 - 42,900.00The 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 TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeReference: R0191154
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