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Batch Disposition Senior Specialist

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Liguria

In loco

EUR 40.000 - 60.000

Tempo pieno

Ieri

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Descrizione del lavoro

A leading pharmaceutical company is seeking a Batch Disposition Senior Specialist to guarantee compliance with quality standards during the production of life-saving drugs. The role involves organizing batch activities, conducting reviews, and providing quality assurance support within the manufacturing process.

Servizi

Health Care Assistance Insurance

Employee Stock Purchase Plan

Employee discount programs on commercial establishments

Technical skill training and professional development

Wellness programs

On-site cafeteria and bar

Competenze

A minimum of 3 / 5 years of experience in Quality or Manufacturing departments within pharmaceutical companies required.
Knowledge of Annex 1 of cGMP for sterile products and ISO regulations is essential.

Mansioni

Organize batch disposition activities and ensure compliance with quality standards.
Execute batch record review within specified timelines and provide quality technical support.

Conoscenze

Good knowledge of JDE systems (ERP system)

Good knowledge of Microsoft Office Word

Good knowledge of written and spoken English

Good understanding of GMP and pharmaceutical regulations

Good ability to work in a team

Precision and accuracy in executing assigned work

Formazione

Degree in scientific disciplines

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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 :

The role of Batch Disposition Senior requires good technical knowledge of the production processes of sterile products, facilities and related equipments, related recording systems and related procedures applied. He / she has a good knowledge of the Quality Management System in order to assure the release activities of finished products in compliance with quality requirements. He / she assures a closely support to the Production department for an effective managing of any occurred issues with GMP impact during the manufacturing process. He / she guarantees the compliance with the procedures and quality standards for the batches of medicinal products and carries out the activities aimed at the release of lots and materials required in the relevant GXP areas. He / she has a great organizational and problem solving skills.

Purpose :

Organize batch disposition activities, based on site prioritization and the Supply Chain requests.
Complete the batch record review within the specified timeline autonomously, ensuring accuracy and compliance.
Collaborate autonomously with department personnel to carry out R&I activities (materials and product bulk lots).
Assure the execution of the release activities of medicinal lots following guidelines and local / global procedures in compliance with quality standards.
Provide Quality technical support to the Manufacturing and Engineering Department, solving issues and making decisions.
Support the deviation issuing related to the manufacturing process

How you will contribute :

Execute the batch record review within the defined timelines, ensuring also the approval of the AQL test and VI overall results
Guarantee the release of the medicinal lots within the requested timelines ensuring the respect of the Lead Time Fullfilment KPI and the compliance with the relevant specification as per Licence
Guarantee the shipment of the medicinal lots within the requested timelines according to the Quality Agreements with the Plants Rieti and Vienna
Support the Receiving and Inspection process in accordance with global / local procedure requirements and cGMP for materials and product bulk lots
Guarantee the quality support to the Manufacturing department, ensuring that potential issues with GMP impact are handled by the deviation management system
Support investigation and CAPA management as needed
Coordinate the activities for a proper training program within the Batch Disposition department
Guarantee the processing of the Key Performance Indicators (KPIs) related to the pertinent area
Take part to meetings / alignment / divisional projects
Execute assigned activities accurately following instructions closely to ensure detail-oriented outcomes.

What you bring to Takeda :

Degree in scientific disciplines
A minimum of 3 / 5 years of experience in Quality or Manufacturing departments within pharmaceutical companies required.
Good knowledge of JDE systems (ERP system), MODA, SQL
Good knowledge of personal computer programs (Microsoft Office Word, PowerPoint).
Good knowledge of written and spoken English.
Good understanding of GMP and pharmaceutical regulations
Good ability to work in a team
Precision and accuracy in executing assigned work
Knowledge of Annex 1 of cGMP for sterile products
Knowledge of ISO 14644-1; 14644-2 regulations
Knowledge of the production process for sterile products

What Takeda can offer you :

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

NOTE :

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

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.

GMSGQ

Locations : ITA - Pisa

Worker Type : Employee

Worker Sub-Type : Regular

Time Type : Full time

Seniority level