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Changes Specialist

Multiple Locations
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On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0122990 Date posted 05/14/2024 Location Multiple Locations

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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.

Locations

ITA - Pisa

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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