Senior Validation Or Validation Sme For New Filling Line Project (osaka Plant)

Takeda

Osaka, Japan
Allowances: commutation, housing, overtime work et...
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Validation strategy creation and execution
Protocol development and execution
Cgmp, gamp5, 21cfr part 11 understanding
** Takeda is seeking a Senior Validation or Validation SME for a new filling line project at its Osaka plant. The ideal candidate will have experience in validation processes for liquid and powder filling, sterilization, and compliance with relevant regulations. **

Job Summary

  • This position is responsible for creating and executing the validation strategy for a new filling line at the Osaka Plant, covering liquid/powder filling, sterilization, C/SIP preparation, and washing machines.
  • Key responsibilities include protocol creation, coordination and execution of validation activities, final report generation, and project planning, with accountability for both initial and re-validation.
  • The role requires daily collaboration with Manufacturing, Engineering, Regulatory Affairs, Quality Control, and Quality Assurance departments, ensuring compliance with cGXP, GAMP5, and relevant regulations.

Matching Summary

Match Score: 75

** Takeda is seeking a Senior Validation or Validation SME for a new filling line project at its Osaka plant. The ideal candidate will have experience in validation processes for liquid and powder filling, sterilization, and compliance with relevant regulations. **

Salary

Allowances: Commutation, Housing, Overtime Work etc.; Salary Increase: Annually; Bonus Payment: Twice a year

Skills & Requirements

Must-have

  • Validation strategy creation and execution
  • Protocol development and execution
  • cGMP, GAMP5, 21CFR Part 11 understanding
  • Cross-functional team coordination
  • Risk analysis and problem-solving
  • Regulatory guideline interpretation

Nice-to-have

  • Process improvement evaluation
  • Leadership and project management skills
  • Innovation in process optimization
  • Experience with isolator aseptic filling

Key Requirements

  • University degree (Pharmacy, Engineering, Science, Agriculture, Chemistry, or Mechanical)
  • 1+ year of validation experience
  • GMP work experience
  • Ability to read/write and communicate in English
  • Experience with isolator aseptic filling processes

Work Rights

Not specified

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