Calibration Specialist - Categorie Protette

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Job Description

Annuncio dedicato alle persone appartenenti alle categorie protette - legge 68/99

JOB TITLE: Calibration Specialist

LOCATION: Pisa

ABOUT THE ROLE:

• 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

• 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:

• Experience in the execution and planning of calibration activities

• Knowledge of the main quality systems (documentation, audit, change control, deviation and training

• 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

• 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

• 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

• Ability to provide input for changes, issues resolution specifically for technical failure analysis on routine/projects processes/systems

• Orientation for continuous improving

• Management of calibration documentation

WHAT YOU BRING TO TAKEDA:

• 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 workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

EMPOWERING OUR PEOPLE TO SHINE:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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