Requirements: English
Company: Takeda
Region: Ospedaletto , Tuscany
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 Takedas 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 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 Specialist requires technical knowledge regarding the production process of sterile products. As a Batch Disposition Lead, you will perform batch record review in compliance with the scheduled timeframes. You will execute activities related to the finished product batch release system and conduct activities associated with the shipment of finished product batches. How you will contribute: Provide technical support to the Production department for Quality aspects and initiate deviations in the Trackwise system. Support activities related to the Receiving and Inspection system (materials and intermediates). Perform batch record review and verification with subsequent approval of visual inspection protocols according to local procedures, adhering to planned timelines. Verify compliance of the necessary data for batch release according to cGMP and local procedures. Carry out the verification process for the shipment of product batches in compliance with global procedure requirements and cGMP, in accordance with the responsibilities defined in the Quality Agreements with Rieti and Vienna plants. Support the Receiving and Inspection process in accordance with global/local procedure requirements and cGMP. Verify the receiving and inspection control executed by the responsible departments and proceed with the approval of raw materials necessary for production activities, monitoring, or laboratory. Write/update department procedures (SOPs, Work Instructions). Check production logbooks/records. Support the Production Department in managing issues with GMP impact that arise during the production process, potentially opening deviations in the electronic system (Trackwise). Support investigations related to production activities/areas and the possible implementation of corrective, preventive, or improvement actions. Verify production processes to ensure compliance with internal and regulatory standards. Participate in Quality projects within own area of expertise with a view to continuous improvement. What you bring to Takeda: Degree in scientific disciplines. A minimum of 3 years of experience in Quality or Manufacturing departments within pharmaceutical companies required. Good knowledge of JDE systems (ERP system), MODA, 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 f