概述

• 薪资

  60,000 THB ~ 85,000 THB

• 工作行业

  Manufacturing(Electronics/Semiconductors)

• 工作内容

  Key Responsibilities：
  - Develop, implement, and maintain a robust Contamination Control Strategy (CCS) to prevent microbial, particulate, and pyrogen contamination.
  - Ensure strict compliance with global regulatory standards, including EU GMP Annex 1, FDA regulations, and ISO cleanroom standards like ISO 14644.
  - Collaborate cross-functionally with Production, Engineering, Maintenance, and Validation teams to preserve cleanroom integrity and enforce hygienic practices
  - Design and manage comprehensive Environmental Monitoring (EM) programs for both viable (bacteria/fungi) and non-viable particulate counts within cleanrooms.
  - Lead technical investigations into EM excursions, out-of-specification (OOS) results, and contamination events using Root Cause Analysis (RCA) tools like 5 Whys, Fishbone diagrams, or FMEA.
  - Utilize Quality Risk Management (QRM) principles (e.g., ICH Q9) to proactively identify and mitigate contamination risks in facility design and manufacturing processes.
  - Design and deliver training programs for personnel on aseptic techniques, gowning qualifications, and general hygiene protocols.