_ Annuncio dedicato_ alle persone appartenenti alle _categorie protette_ - _legge 68/99_ JOB TITLE: Calibration Specialist LOCATION:Pisa ABOUT THE ROLE: _ OBJECTIVES/PURPOSE _ - Ensure the management and execution on the shop floor of calibration activities, according to the annual planning and in compliance with GMP - Collaborate for the planning of calibration activities (periodic, corrective and project related) and KPI analysis and follow up _ ACCOUNTABILITIES_ - Accountable for unplanned calibration activities - Accountable for Issuance and management of calibration certificates - Accountable for the correct planning of calibration activities (periodic, corrective and project related) and responsible for execution of activities on time with respect of calibration KPI - Accountable for external companies’ calibration contracts for ordinary and extraordinary interventions - Responsible for calibration procedure on Pisa Plant - Responsible for the execution of calibration activities on time in accordance with company procedures Responsible as owner of the calibration Corrective Action Plan Activities and Deviation Reports. - Responsible for the calibration activities executed by third parties including on the floor supervision - Responsible for training and leading external support companies - Collaborate for the approval of calibration documentation and certificate - Updating of the calibration program of the Pisa plant (RAM Dataset) - Managing deadlines, Change Control activities /tasks as assigned - Guarantee communications with Customers and Interfaces for the assigned duties and items - Responsible for calibration consumables management - Responsible for maintaining the document correctly archived - SME (Subject Matter Expert) of calibrations during external and internal audits - Support as Calibration SME other sites by sharing know-how - Support as Calibration SME to global initiatives implementation - Assure the technical/functional quality of calibration on the floor activities - Assure the safe execution of calibration activities - Participate to meetings for the planning of calibration activities - Management of calibration activities on JDE and RAM systems HOW YOU WILL CONTRIBUTE: Technical/Functional (Line) Expertise - Experience in the execution and planning of calibration activities - Knowledge of the main quality systems (documentation, audit, change control, deviation and training Leadership - Ability to focus on priority plant, departmental and process objectives and reorganize the work consequently - Spirit of collaboration and ability to adapt proposing alternative and/or innovative solutions - Be results oriented, enables the project team to work collaboratively, have challenging discussions Decision-making and Autonomy - Ability to work alone (without direct control) and in team creates clarity, fostering alignment and accountability - Able to find effective solutions to daily issue, based on sound business judgment - Able to structure activities and processes reducing unnecessary complexity Interaction - Good communication skills, influences others to adopt new and effective ways of working - Guarantee communications with Customers and Interfaces for the assigned duties and items - Accountable for external companies’ calibration contracts for ordinary and extraordinary interventions - Collaborate with Validation and Quality Validation SME Innovation - Ability to provide input for changes, issues resolution specifically for technical failure analysis on routine/projects processes/systems - Orientation for continuous improving Complexity Management of calibration documentation EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: - High school certification in technical discipline At least 5 years of previous experience in this role or equivalent within pharmaceutical, biotechnology, or related industry, familiar with Quality Management and GxP Regulations - Technical English (written and spoken); - Analytical skills with systematic approaches to problem solving; - Familiar with Quality Management and GxP Regulations - Proficiency in the following software: - Microsoft Office (Excel; Word; Powerpoint) - Validation Programs ( Kneat System) - Instruments (Ellab; Kaye; Viasala; Sensitech; RAM and JD Edwards) - Quality Management Software (Trackwise, Veeva - Bloom platform) - Support as SME the Quality Assurance during internal or external Audit presenting Calibration Documents MORE ABOUT US: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative work