Pharmaceutical Manufacturing Control Pharmacist (Pharmaceutical Company)
いやくひんせいぞうかんりやくざいし
Industry & Occupation
Classification
- Major : Medical, Nursing, and Health Occupations
- Middle : Physicians, Dentists, Veterinarians, and Pharmacists
- Minor : Pharmacists
Summary
A specialist who manages the manufacturing processes and quality of pharmaceuticals in pharmaceutical factories, ensuring compliance with laws, regulations, and GMP standards.
Description
Pharmaceutical manufacturing control pharmacists perform manufacturing management tasks based on GMP (Good Manufacturing Practice) at manufacturing sites of pharmaceutical companies. They maintain quality and safety through manufacturing planning, process monitoring, batch record verification, responses to abnormalities, implementation of corrective actions, and internal audit support. They collaborate with various departments in pharmaceutical factories (quality assurance, quality control, engineering, inspection departments) and play a crucial role in product shipment decisions. They contribute to process improvements and troubleshooting by staying updated on the latest laws, regulations, and technological trends.
Future Outlook
With expanding demand for pharmaceuticals both domestically and internationally, particularly the increasing sophistication of manufacturing management for biopharmaceuticals and advanced therapeutic drugs, demand for specialized manufacturing control pharmacists is on the rise.
Personality Traits
Attentive / Good team player / Patient / Strong sense of responsibility
Work Style
Career Path
Manufacturing Control Pharmacist → Quality Assurance Responsible Person → Plant Manager / Manufacturing Manager → Head Office QA/QC Department → Senior Management Position
Required Skills
Abnormality Response and Corrective Actions / Document Management / GMP Knowledge / Manufacturing Process Management / Pharmaceutical Regulations Knowledge
Recommended Skills
Data Analysis / English Document Reading Skills / Project Management / Statistical Quality Control
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Analytical & Logical Thinking | Required for optimizing manufacturing processes and problem analysis. |
| Attention to Detail & Accuracy | Because small recording errors or deviations from standards directly affect safety. |
| Learning Agility & Knowledge Acquisition | Because laws, regulations, and technologies are frequently updated. |
| Planning & Organization | To comprehensively manage multiple processes and schedules. |
| Problem Solving | Essential for investigating causes and corrective actions when abnormalities occur. |
Aptitudes (Weaknesses Acceptable)
| Item | Description |
|---|---|
| Physical Stamina & Endurance | Primarily desk work and light tasks indoors. |
Related Qualifications
- Pharmacist License
Aliases
- GMP Management Pharmacist
- Manufacturing Supervisor
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