Requirements: English
Company: Thermo Fisher Scientific Inc.
Region: Monza , Lombardy
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionHow will you make an impact?The pharmaceutical manufacturing plant in Monza specializes in commercial contract manufacturing of injectable drugs, including liquids and lyophilized products, with a growing focus on biologics.You will join the Master Batch Record team, responsible for defining manufacturing instructions based on client requests.You will apply your technical skills in a fast-paced environment, working with top clients to deliver medicines worldwide.What will you do?Create and revise Master Batch Records to ensure cGMP compliance with EMA and US FDA requirements.Train personnel and check the correct application of GMP and operating procedures.Collaborate throughout different project phases for implementation and validation.Implement CAPAs and actions from Change Control in the MBRs.Participate in technical meetings with clients to introduce new processes/products and revise MBR instructions via calls or meetings.Support internal audits, client audits, and regulatory inspections.Manage client requests related to production processes.Collaborate with Quality Operations, Process Science, MSAT, Equipment Validation, Supply Chain, and Production departments.Participate in training courses.Knowledge, Skills, AbilitiesDegree in Chemistry, Chemical, Pharmaceutical Technology, Industrial Engineering, or equivalent experience.GMP and pharmaceutical manufacturing knowledge, especially of sterile products, is preferred.Proficiency in Outlook Package.Good command of English (written and spoken).At Thermo Fisher Scientific, each of our 100,000 outstanding individuals has an exceptional story to share.#J-18808-Ljbffr