Senior Validation Or Validation Sme For New Filling Line Project (osaka Plant)
Takeda UK
Osaka, Japan
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Create and execute validation strategy
Develop and execute validation protocols
Cgmp, gamp5, 21cfr part 11 understanding
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Takeda UK is seeking a Senior Validation SME for its new filling line project at the Osaka plant. The role involves creating and executing validation strategies for liquid and powder filling processes, ensuring compliance with regulatory requirements, and collaborating across various departments.
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Job Summary
This position is responsible for creating and executing the validation strategy for the new filling machine line at the Osaka Plant, including liquid filling, powder filling, sterilization, C/SIP chemical preparation lines, and cleaning machines.
Key responsibilities include protocol creation, coordination of validation work, execution of validation, final report creation, and project planning, with responsibility for both initial and re-validation.
The role requires collaboration with manufacturing, engineering, regulatory affairs, quality control, and quality assurance departments on a daily basis.
Matching Summary
Match Score: 75
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Takeda UK is seeking a Senior Validation SME for its new filling line project at the Osaka plant. The role involves creating and executing validation strategies for liquid and powder filling processes, ensuring compliance with regulatory requirements, and collaborating across various departments.
**
Skills & Requirements
Must-have
Create and execute validation strategy
Develop and execute validation protocols
cGMP, GAMP5, 21CFR Part 11 understanding
Cross-functional team leadership
Risk analysis and problem-solving
Nice-to-have
Experience with isolator aseptic filling
Interaction with regulatory authorities
Process optimization leadership
Key Requirements
University degree (Pharmacy, Engineering, Science, Agriculture, Chemistry, or Mechanical)