Calibration Specialist

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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