【800～1200万円】MS T Expansion Lead RLT Sasayama

【求人No NJB2225066】
【Job Description Summary】
The purpose of the job is to lead and execute the technical activities related to site according to project timeline without delays in the execution. The person must ensure process technology and product is transferred to the site and will act as the go to person for MS T related activities withing the project and during transfer and implementation.
Responsible for technology transfer activities at site level （within inbound and outbound） including any scale up or other process adaptations.
Leads 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）

【Job Description】
Technical transfer milestones achieved in time and in full. Including schedule for registration and launches.
Robust manufacturing process delivering critical quality attributes.
Analytical methods in place meeting cGMP standards.
No critical observations during internal and external GMP inspections and Pre Approval Inspections （PAI）.
Adheres to project / Capital Approval Request CAR costs
Stewardship ・ Manage change control for process transfers and process adaptations and modifications
Validation ・ Ensure that all relevant technical information and documentation for validation is available.
Launch Transfer Act as SPOC on site for technical transfer
Manufacturing Excellence ・ Contribute to process improvement and optimization for product transfers.
Training Own the Training Curriculum for own Job Profile and direct reports.
Novartis Manufacturing Manual Support implementation of Novartis Manufacturing Manual principle 3.