Pharmaceutical Analyst (Pharmaceutical Manufacturing)

やくひんぶんせきいん

Industry & Occupation

Engineering & Manufacturing

Classification

Summary

A profession that inspects and analyzes the quality of raw materials, intermediates, and products in pharmaceutical manufacturing processes using chemical methods.

Description

Pharmaceutical analysts are specialists who inspect and evaluate the chemical composition and purity of raw material samples, manufacturing intermediates, and final products using various analytical instruments. They prepare reagents, perform sample pretreatment, and operate equipment such as HPLC, GC, spectrophotometers, and mass spectrometers. They analyze the obtained data using statistical methods, determine compliance with standards based on GMP (Good Manufacturing Practice), and compile results into reports. They collaborate with manufacturing, development, and quality assurance departments, and are also involved in method optimization, troubleshooting, and safety and health management.

Future Outlook

Due to strengthening of quality regulations in pharmaceutical manufacturing and increase in new drug development, demand is expected to remain stable. With the introduction of automation and online analysis, there is a trend toward requiring even higher specialized knowledge.

Personality Traits

Curious or inquisitive / High concentration / Meticulous / Strong sense of responsibility

Work Style

Clean room / Fixed hours / Shift work / Team lab

Career Path

Lab Technician → Senior Analyst → Quality Control Manager → Manufacturing Technology Leader → Quality Assurance Manager

Required Skills

Data Analysis / GC Operation / GMP Knowledge / HPLC Operation / Sample Pretreatment

Recommended Skills

English Literature Reading Comprehension / Instrument Calibration and Maintenance / LIMS Operation / Mass Spectrometry Equipment Operation

Aptitudes (Strengths Preferred)

Item Description
Analytical & Logical Thinking Ability to accurately analyze and interpret complex data is essential.
Attention to Detail & Accuracy Because minute errors can greatly affect analysis results.
Numerical & Quantitative Analysis Because quantitative analysis and result evaluation based on statistical methods are required.

Related Qualifications

  • Certified Analytical Chemist
  • Chemical Analysis Technology Certification
  • Hazardous Materials Handler (Type B Class 4)

Related Jobs

  • Chemical Product Manufacturer
  • Formulation Technician
  • Quality Control Engineer

Tags

Keywords