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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 withTakeda'sPrivacy NoticeandTerms of Use.I further attest that all information I submit in my employment application istrue 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 S eniorrequires good technical knowledge of the production processes ofsterileproduct s , facilities and relatedequipments , related recording systems and related procedures applied.He/shehas a good knowledge of theQuality Management Systemin order toassurethe release activities offinished productsincompliance with qualityrequirements .He/sheassure sacloselysupport to the Production department for an effectivemanagingof anyoccurred issueswith GMP impactduring themanufacturingprocess .He/sheguaranteesthe compliancewith the procedures and quality standards for the batches of medicinal products and carries out the activities aimed at the release oflotsand materialsrequiredin the relevant GXP areas.He/shehasagreatorganizationalandproblem solvingskills.Purpose:Organizeb atchd isposition activities, based on site prioritizationand the Supply Chain requests .Complete the batch record review within the specified timeline autonomously, ensuring accuracy and compliance.Collaborate autonomously with d epartment personnel to carry out RI activities (materials and product bulk lots).Assure the execution of the release activities ofmedicinallotsfollowing guidelinesand local/global proceduresincompliance with quality standards.Provide Quality technical support to the Manufacturing and Eng i neeringDepartment, solving issues and making decisions.Support the deviation issu ingrelated to the manufacturing processHow you will contribute: Execute the batch record reviewwithin the defined timelines,ensuringalsothe approval of the AQL test and VI overall resultsGuarantee the release of themedicinallots within the requested timelines ensuring the respect of the L ead TimeFullfilmentKP I and the compliance with the relevant specification as perLicenceGuarantee the shipment of the medicinallotswithin the requested timelines according to the Quality Agreements with the Plants Rieti and ViennaSupport the Receiving and Inspection processin accordance withglobal/local procedure requirements and cGMPfor materials andproduct b ulk lotsGuarantee the quality support to the Manufacturing department, ensuring that potential issues with GMP impact are handled bythe deviation management systemSupport investigation and CAPA management as neededCoordinate the activities for a proper training programwithin theBatch DispositiondepartmentGuarantee the processing of the Key Performance Indicators (KPIs)related to the pertinent areaTake part to meetings/alignment/divisional projectsExecute assigned activities accurately following instructions closely to ensure detail-oriented outcomes.What you bring to Takeda: Degree in scientific disciplinesA 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 regulationsGood communication skillsGood ability to work in a teamPrecision and accuracy in executing assigned workKnowledge of Annex 1 of cGMP for sterile productsKnowledge of ISO 14644-1; 14644-2 regulationsKnowledge of the production process for sterile productsWhat 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 InsuranceEmployee Stock Purchase PlanEmployee discount programs on commercial establishments, shops, medical servicesTraining and Development Technical skill training and professional developmentJob Rotation programs for working in other departmentsSpontaneous employee groups for awareness on Diversity, Equity, and Inclusion issues and community engagement activitiesValue-based cultureIndividual Support Wellness programsOn-site cafeteria and barResources for mental, physical, financial, and spiritual healthParental LeaveNOTE: 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 - Pisa Worker TypeEmployee Worker Sub-TypeRegular Time TypeFull time