Calibration Coordinator

5 mesi fa


Pisa, Italia Takeda Pharmaceutical A tempo pieno

**Sarà considerato requisito preferenziale l'appartenenza alle categorie protette** (legge n. 68/99)

**Job Title: Calibration Coordinator**

**Location: Pisa**

**_ 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)

**_ ACCOUNTABILITIES _**
- Accountable for unplanned calibration activities
- Accountable for Issuance and management of calibration certificates
- Management of calibration activities on JDE and RAM systems and calibration program of the Pisa plant (RAM Dataset)
- 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
- Collaborates for external companies’ calibration contracts definition for ordinary and extraordinary interventions
- Responsible of the calibration Corrective Action Plan Activities and Deviation Reports.
- Responsible for the calibration activities executed by third parties including on the floor supervision, their technical/functional quality and safe execution.
- Responsible for calibration consumables management
- Responsible for maintaining the document correctly archived

**_ DIMENSIONS AND ASPECTS _**

**Technical/Functional (Line) Expertise**
- Experience in the execution and planning of maintenance or calibration activities
- Knowledge of the main quality systems (documentation 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 structure activities and processes reducing unnecessary complexity

**Interaction** _(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)_
- Good communication skills, influences others to adopt new and effective ways of working

**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
- Analytical skills with systematic approaches to problem solving;
- Familiar with Quality Management and GxP Regulations
- Support as SME Maintenance 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.

**Locations**:
ITA - Pisa

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time