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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 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 DescriptionSarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)Job Title: Manufacturing Change Control GMP Documentation Location: RietiABOUT THE ROLEIn this role, you will guarantee production support activities by managing and revising GMP documentation, executing training, overseeing change requests and risk assessments, providing project support, and assisting in the preparation for internal and external audits.HOW YOU WILL CONTRIBUTEIssue and review of GMP DocumentationSupport the maintenance of the GMP documentation archive related to own department, including the responsibility to collect and destroy documentsProject management and change request opening and managementSupport MES project implementationCarrying out activities relating to GMP compliance in the field and operational problem solvingIdentification of improvement opportunities to align GMP compliance in productionWriting/Executing/reviewing RAPerformance of staff training regarding specific operating procedures, in compliance with the principles of Lean ManufacturingSupport in preparing and carrying out internal and external auditsWHAT YOU BRING TO TAKEDABS in Life Sciences or a related fieldAt least 3 years of manufacturing experienceKnowledge of cGMP as it applies to the production processStrong understanding of computer systems and key software and applications used in the pharmaceutical industrySolid knowledge of scientific principles and pharmaceutical manufacturing equipmentExpertise in quality risk managementStrong organizational and personnel management skillsExcellent relationship-building and communication abilitiesProficient in data analysisSkilled in problem-solvingProven ability to manage and lead teamsGood mastery of the English languageMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused 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 strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering our people to shine:Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.LocationsITA - RietiWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time