By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionSince 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 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 close support to the Production department for effective management of any issues with GMP impact during the manufacturing process. He/she guarantees 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 great organizational and problem-solving skills.Purpose:Organize batch disposition activities, based on site prioritization and 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 RI 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 compliance with the relevant specification as per License.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 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 in 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 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 FinanceHealth Care Assistance Insurance.Employee Stock Purchase Plan.Employee discount programs on commercial establishments, shops, medical services.Training and DevelopmentTechnical 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 SupportWellness 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.#GMSGQ#LI-LA1LocationsITA - PisaWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
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