Active Pharmaceutical Ingredient Manufacturing Worker
げんやくせいぞうこう
Industry & Occupation
Classification
Summary
Manufacturing technician responsible for production processes such as synthesis, reaction, purification, and drying of active pharmaceutical ingredients (API), the active components of pharmaceuticals.
Description
The active pharmaceutical ingredient manufacturing worker is responsible for manufacturing active pharmaceutical ingredients (Active Pharmaceutical Ingredient: API), the active ingredients in pharmaceuticals. Performs reaction operations through organic chemical synthesis, purification processes such as liquid-liquid separation, filtration, distillation, and crystallization, drying, pulverization, and final quality confirmation records. In compliance with GMP (Good Manufacturing Practice), strict record management for each process and maintenance of quality standards are required. Work in cleanroom environments and wearing of protective gear may be necessary, and equipment inspections and initial responses to equipment malfunctions are also performed.
Future Outlook
Due to the maintenance and expansion of domestic manufacturing bases in response to an aging population, as well as increasing demand for biopharmaceuticals and generic drugs, demand for technicians is expected to remain stable.
Personality Traits
High safety awareness / Meticulous / Strong sense of responsibility
Work Style
Career Path
Operator → Team leader → Process manager → Manufacturing department manager → Production planning and improvement staff
Required Skills
Chemical safety and hygiene / Manufacturing record preparation / Reactor operations / Separation and purification process operations / Weighing operations
Recommended Skills
Analytical chemistry (HPLC, GC) / Basic GMP knowledge / Cleanroom work experience / Process optimization
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Attention to Detail & Accuracy | Because errors in reaction conditions or weighing directly affect product quality. |
| Physical Stamina & Endurance | Because it requires physical stamina for long hours of standing work and wearing protective gear. |
Aptitudes (Weaknesses Acceptable)
| Item | Description |
|---|---|
| Creativity & Ideation | Because it follows standard operating procedures, creative thinking is not particularly required. |
| Initiative & Leadership | Because work is basically performed following instructions. |
Related Qualifications
- Dangerous Goods Handler (Class B, Category IV)
- Forklift Operation Skills Training
Aliases
- API Manufacturing Technician
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