Cleaning Validation Specialist

**JOB TITLE: CLEANING VALIDATION SPECIALIST**

**LOCATION: RIETI**

ABOUT THE ROLE:
OBJECTIVES/PURPOSE
- Support and execute validation activities related to equipment cleaning procedures.
- Develop and execute validation documents as appropriate in compliance with main internal and external guidelines and policies.

HOW YOU WILL CONTRIBUTE:
ACCOUNTABILITIES
- Writes I reviews cleaning validation Protocols
- Writes / reviews cleaning validation Final Reports
- Writes I reviews cleaning validation Risk Assessments
- Performs trainings related to cleaning validation activities
- Participates in the execution or supervises the execution of the validation protocols
- Collaborates with production for the drafting of cleaning procedures and the management I scheduling of validation activities.
- Collaborates with QC for analysis planning, management and flow of samples as part of cleaning validation studies.
- Supports the maintenance of GMP archive through correct management of data

collection, document consultation, retrieval, return and archiving.

DIMENSIONS AND ASPECTS

**Technical/Functional (Line) Expertise**

Experience related to:

- Execution and coordination of assigned Validations related to cleaning procedures of

product contact equipment.
- Knowledge of the main quality systems (documentation, audit, change control, training)

**Leadership**

Ability to work alone and in team, have good and direct communication skills

Ability to Coordinate resources for some specific task/activity.
- Be Positive
- Be Responsible
- Be results oriented

**Decision-making and Autonomy**
- Ability to perform Routine Tasks with limited Supervision
- Ability to represent department in meetings for assigned topics

**Interaction**

Be able to manage relationships:

- Internal relationship: Production, Engineering, Quality, QC Quality validation,

Manufacturing science
- External relationship: Suppliers for external consultants services

**Innovation**
- Provide Input for Changes, Issues resolution
- May support other sites by sharing know how

**Complexity**
- Definition of validation strategies, identification of the appropriate criteria to be adopted in

qualifying and evaluation of the results obtained.
- Management of validation documentation.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- Degree in Engineering, Chemistry, Life Science, or other job related discipline + At

least 1 years of previous experience in this role or equivalent within pharmaceutical,

biotechnology, or related industry, familiar with Quality Management and GxP

Regulations
- Fluent English (written and spoken);
- Analytical skills with systematic approaches to problem solving.
- Familiar with Quality Management and GxP Regulations
- Proficiency in Microsoft Office

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 - Rieti

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time