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Job Description

Since 1972, Takeda has had two sites in Italy for producing plasma-derived drugs in Rieti and Pisa, supporting patients with rare and complex diseases. These sites focus on the production of therapies derived from immunoglobulins, albumin, and coagulation factors. As a partner of the National Health System, we transform plasma into life-saving drugs under the “National Self-Sufficiency of Blood and its Products” program. We provide high-quality drugs worldwide, with a strong presence in Europe, America, and Asia.

Across Italy and the world, Takeda is recognized as a Top Employer by the Top Employers Institute based on our commitment to career development, inclusion, learning, sustainability, wellness, and, most importantly, our values.

Join us to make a difference.

About the role:

As a Quality Control Analyst, you will ensure computer systems and analytical instruments validation documentation, inclusive of validation plans, system design and configuration, periodic reviews, and operational activities in alignment with the Computer System Validation and Analytical Instrument Qualification lifecycle process.

How you will contribute:

• Ensure the planning, development, and implementation of validation documentation and activities.

• Ensuring adherence to data integrity standards, and procedures for computer related analytical laboratory instruments.

• Provide validation leadership for GXP laboratory analytical instrument/ computerized systems and applies risk-based methodology to validation and qualification efforts.

• In compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5

• Serves as the liaison between QC department, IT and quality functions, provides timely and effective response and follow-through in issue resolution during installation and qualification activities

• Prioritize, plan and actively participate in multi-tasking validation AIQ activities within agreed timelines

What you bring to Takeda:

• Master;s degree (5 years) in Science - Chemistry, Pharmaceutical Chemistry or Biology/Biotechnology and Engineering)

• 1 - 2 years of previous experience in QC dept (internship or short-term contract experience)

• Experience with Microsoft Office applications (Excel, PowerPoint, Word)

• Knowledge of requirements related to quality control and 21 CFR Part 11, EU Annex 11, and GAMP 5

• English knowledge and communication skills (verbal and written, including technical writing).

• Ability to work a flexible schedule and adapt efficiently to program changes.

What Takeda can offer:

We want our employees to succeed in everything they do - at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.

Health and Finance

• Health Care Assistance Insurance

• Employee Stock Purchase Plan

• Employee discount programs on commercial establishments, shops, medical services

Training and Development

• Technical skill training and professional development

• Job Rotation programs for working in other departments

• Spontaneous employee groups for awareness on Diversity, Equity, and Inclusion issues and community engagement activities

• Value-based culture

Individual Support

• Wellness programs

• On-site cafeteria and bar

• Resources for mental, physical, financial, and spiritual health

• Parental Leave

NOTE:

• Belonging to protected categories (Law No. 68/99) will be considered a preferential qualification.

Important Considerations:

At Takeda, our patients rely on us to create quality products, and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wearing protective clothing.

• Need to remove all make-up, jewelry, contact lenses, nail polish,and/or artificial fingernails while in the manufacturing environment.

More About Us:

At Takeda, we are transforming patient care through the development of innovative specialty medicines and first-class patient support programs. Takeda is a patient-oriented 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 aims for excellence in everything we do. We promote an inclusive and collaborative work environment where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people worldwide.

Empowering our people to shine:

Takeda is proud of its commitment to creating a diverse workforce and offering equal employment opportunities to all employees and applicants without distinction of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or any other characteristic protected by law.

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