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Job Description

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

Job Title: Manufacturing Change Control & GMP Documentation

Location: Rieti

ABOUT THE ROLE

In this role, you will guarantee production support activities by managing and revising GMP documentation, executing training, overseeing change requests and risk assessments, providing project support, and assisting in the preparation for internal and external audits.

HOW YOU WILL CONTRIBUTE

• Issue and review of GMP Documentation
• Support the maintenance of the GMP documentation archive related to own department, including the responsibility to collect and destroy documents
• Project management and change request opening and management
• Support MES project implementation
• Carrying out activities relating to GMP compliance in the field and operational problem solving
• Identification of improvement opportunities to align GMP compliance in production
• Writing/Executing/reviewing RA
• Performance of staff training regarding specific operating procedures, in compliance with the principles of Lean Manufacturing
• Support in preparing and carrying out internal and external audits

WHAT YOU BRING TO TAKEDA

• BS in Life Sciences or a related field
• At least 3 years of manufacturing experience
• Knowledge of cGMP as it applies to the production process
• Strong understanding of computer systems and key software and applications used in the pharmaceutical industry
• Solid knowledge of scientific principles and pharmaceutical manufacturing equipment
• Expertise in quality risk management
• Strong organizational and personnel management skills
• Excellent relationship-building and communication abilities
• Proficient in data analysis
• Skilled in problem-solving
• Proven ability to manage and lead teams
• Good mastery of the English language

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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