PbJob Description Summary /b /pThe Technical Transfer Lead is responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations.brLeading technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.).pbJob Description /b /ppbMajor accountabilities: /b /pullipReview and update Quality Risk Assessment (QRA) prior to transfer and prior to validation, adapt control strategy if needed. /p /lilipEnsure that all relevant technical information and documentation for validation is available. /p /lilipDefine pre-validation / validation strategy incl. process, cleaning, packaging and supportive studies (e.g., hold times). Coordinate technical, regulatory and validation batches at site. /p /lilipSupport Validation Lead / Validation Expert in creation of validation protocol and report. /p /lilipPerform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer. /p /lilipEstablish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategies, and timelines. /p /lilipForm and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met. /p /lilipEnsure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report). /p /lilipReview key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate). /p /lilipLiaise with global project manager, giving site (CMC team for development transfers) and site functions. Ensure knowledge transfer from giving site to receiving site including to operators. /p /lilipAccountable to coordinate inter-functional evaluation and implementation phases of change requests related to Drug Products /p /li /ulpbMinimum Requirements: /b /pullipScientific Degree. /p /lilipPrevious solid experience in a similar role within the Tech Transfer/ MST/QA/Production department of a GMP environment. /p /lilipProject management experience. /p /lilipFluent in Italian and English. /p /li /ulpbSkills Desired /b /pApplied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer #J-18808-Ljbffr