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Production Support Supervisor

JOB TITLE: PRODUCTION SUPPORT SUPERVISOR
LOCATION: RIETI

ABOUT THE ROLE:

  • Management of work performance and activities of direct reports involved in production business related to:
  • Management of all the activities requested to issue, to distribute and to continuously review production documentation, maintenance of cGMP compliance and related training
  • Production Change control management, including related risk assessment
  • Support of site project execution in Production area and continuous improvement processes
  • Support of site project execution in Cleaning, Process Validation, Mixing and Technical Operations
  • Support CAPA identification. Collaboration for audit execution

HOW YOU WILL CONTRIBUTE:

  • Guarantee and organize the Production documentation creation, review and distribution (Master Batch Records, SOPs, Forms, Logbooks)
  • Organize the training on production procedures
  • Organize Change Control issuing and activities execution with impacts on production. Support risk assessment issuing and evaluation (quality risk management)
  • Collaborate with regulatory authorities’ audits. Support preparation and execution. Support the dossiers renewals.
  • Support and organize production activities to execute process & cleaning validation, technical operation, mixing studies and all the other activities with impact on Production process/equipment
  • Manage and execute continuous improvement projects in Production area
  • Support the design of MES application in Production areas
  • Support the maintenance of the GMP documentation archive related to own department, including the responsibility to collect and destroy documents

WHAT YOU BRING TO TAKEDA:

  • Technical/Functional (Line) Expertise Good computer system knowledge and main software and applications used in the pharmaceutical industries
  • Good science knowledge and main principles of pharmaceutical manufacturing equipment
  • Quality risk management (ICH9)
  • Leadership
  • Organizational and personnel management skills
  • Relationship and communication skills
  • Data analysis
  • Decision-making and Autonomy
  • Problem solving
  • Risk management
  • Decision making
  • Ability to manage and lead teams of people
  • Interaction
  • Communication skills
  • Ability to lead multi-functions teams (Engineering, Quality, Supply Chain, Validation, Training, ect)
  • Innovation P
  • Propose innovative and decisive solutions
  • Basic knowledge of MES application in Pharma industries
  • Main IT applications
  • Complexity
  • Project management
  • Business administration

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

  • BS in life sciences or related field
  • Good english knowledge
  • Manufacturing experience at least 4 years
  • BS in life sciences or related field (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry, Engineering)

 

Degrees of interest: Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry, Engineering