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Job Description

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

Job Title: Changes Specialist

Location: Pisa

OBJECTIVES/PURPOSE:

As a Changes Specialist you will oversee the management of all activities related to production documentation ownership, including revision, issuance, and maintenance of documentation according to GDDP rules, ensuring cGMP compliance, and execution of related training. You will also be in charge of Production Changes, including related risk assessments.

ACCOUNTABILITIES:

• Execute documentation revision, issuance, maintenance (Master Batch Records, SOPs, forms, logbooks, visual aid) according to GDDP rules and cGMP compliance.

• Execute effective training of Production documentation of its ownership.

• Execute Change Control activities with impacts on production and support those through adequate and strong risk assessment (quality risk management).

• Collaborate with regulatory authorities’ audits.

• Execute production activities as support to process, cleaning validation and technical operation activities with impact on Production process/equipment.

WHAT YOU BRING TO TAKEDA:

• Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).

• 3-5 years of experience in pharmaceutical companies

• Deep knowledge of aspetic production process.

• Deep knowledge of GMP regulations and manufacturing of sterile products with RABS/Isolators.

• Organizational, analysis and prioritization ability.ommunication skills, ability to influence other.

• Flexibility, ability to rapid adaption to changes.

• Ability to take/propose decisions based on risk evaluation.

• Strong team-working ability and results orientation.

• Problem solving ability.

• Good knowledge of English and of the main IT applications (Word, Excel, Power Point).

• Knowledge of Trackwise System is a plus.

• Oriented in digitalization/innovation of systems/process.

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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