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Manufacturing Specialist (BB-17887)

Trouvé dans: Xpatjobs BE

Description:
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 Manufacturing Sciences (MS) at Takeda Lessines Facility is a group that provides day to day support for manufacturing operations across the network, as well as creative and innovative solutions to ensure sustainable and enhanced process capabilities. It develops process improvements and provides scientific & technical expertise to the facility manufacturing operations (purification and fill-finish activities for blood-derivative products). Focus areas are improving the process robustness, achieving higher capacity and process yields, performing quality assessments and leading complex investigations. The Manufacturing Sciences group also works closely with Global Organization for the implementation and transfer of new processes and technologies into the regular manufacturing. It is composed of the following dynamic teams: MS Laboratory, Digital & Data Science, Process Validation, and Process Sciences and Material Qualification (PS & MQ). Summary The Manufacturing Science Specialist is part of the PS & MQ team. He/She works on process improvements (yield increase, process robustness, capacity increase) and supports such projects from start to implementation, including the submission preparation. He/She leads risk analyses for existing manufacturing processes as well as for new/upgraded processes. He/She leads cross-functional groups (also with other facilities), evaluates possible actions to mitigate/reduce the effect of the identified risks, and ensures the follow-up of the implementation of the actions. He/She also handles large and complex investigations related to manufacturing processes, ensures that appropriate impact assessments are performed, and that adequate corrective actions are implemented in a timely manner. He/She defends such investigations in front of regulators. Responsibilities: Handles complex CAPA investigations related to manufacturing operations. In view of this: - Uses Six Sigma and DMAIC methods where appropriate. - Defines tasks/experiments to be performed, provides required documentation and ensures also that adequate corrective actions are implemented to address the identified root-cause(s). - Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities. - Ensures and defends the Compliance to cGMPs, GDPs, Licenses and Takeda Procedures by defining, implementing and maintaining appropriate SOPs and training. - Favors communication, critical thinking, problem solving and team work across all manufacturing facilities. - Defends investigations in front of regulators during audits. Develops and leads projects that will improve yields, throughput & process efficiency, production process control and/or will reduce process variations. In view of this: - Uses QbD, DIDOV, Lean and implements new technologies (including PAT) where appropriate. - Conducts risk analyses for existing manufacturing processes as well as for new/upgraded processes (Capacity increase, Change Request, ), evaluate and implement actions to mitigate/reduce the identified risks. - Defines tasks/experiments to be performed, provides required documentation and leads the project from start to the implementation, including the submission preparation. - Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities. - Ensures and defends the Compliance to cGMPs, GDPs, Licenses and Takeda Procedures by defining, implementing and maintaining appropriate SOPs and training. - Favors communication, critical thinking, problem solving and team work across all manufacturing facilities. - Defends submissions in the role of recognized process expert. As a recognized process expert: - Is involved in technology transfers, CMO related activities - Ensures training of personnel on Scientific & Technical topics Profile: - Master or PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry or equivalent by experience - 3 to 5 years in Pharmaceuticals & Bio-therapeutics manufacturing, in a similar function - GMP and bioprocessing knowledge and experience - Experience with Technical writing (in English) in preparation of regulatory submission files and defending topics during a FDA or cGMP audit - QbD, DOE, pFMEA, Lean, Six Sigma and DMAIC methods/tools as appropriate - Optimism, realism, innovation, critical thinking, problem solving, team

calendar_todayil y a 5 jours

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location_on Lessines, Belgique

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