Batch Disposition Senior Specialist

Takeda; Ospedaletto; In loco; EUR 35.000 - 65.000; Tempo pieno

Descrizione del lavoro

Un'azienda innovativa cerca un Senior Batch Disposition per gestire i processi di produzione di prodotti sterili. In questo ruolo, sarai responsabile della revisione dei registri di produzione, della garanzia della conformità alle normative GMP e del supporto al dipartimento di produzione. Con un focus sulla qualità e sull'accuratezza, avrai l'opportunità di contribuire a un ambiente di lavoro collaborativo e inclusivo, dove ogni giorno puoi fare la differenza nella vita dei pazienti. Unisciti a noi per un'opportunità stimolante che promuove la crescita personale e professionale.

Servizi

Assicurazione sanitaria

Piano di acquisto azionario per i dipendenti

Programmi di sconto per dipendenti

Formazione tecnica e sviluppo professionale

Programmi di benessere

Cafeteria e bar in loco

Congedo parentale

Competenze

• 3-5 anni di esperienza in qualità o produzione in aziende farmaceutiche.
• Ottima conoscenza dei sistemi di gestione della qualità.

Mansioni

• Organizzare attività di disposizione dei lotti e garantire la conformità alle normative.
• Collaborare con il personale per gestire le attività di rilascio dei lotti.

Conoscenze

Conoscenza dei processi di produzione

Competenze di problem solving

Conoscenza delle normative GMP

Competenze comunicative

Precisione e accuratezza

Capacità di lavorare in team

Conoscenza dell'inglese scritto e parlato

Formazione

Laurea in discipline scientifiche

Strumenti

JDE systems (ERP)

MODA

SQL*LIMS Labware

Trackwise

Microsoft Office

Descrizione del lavoro

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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 equipment, 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 Fulfillment 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*LIMS Labware, Trackwise.

• 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 communication skills.

• 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.

• 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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Locations

ITA - Pisa

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time