Chemist

Kotra Pharma (M) Sdn Bhd; Malacca City; On-site; MYR 60,000 - 90,000; Full time

Job summary

Kotra Pharma (M) Sdn Bhd is seeking an experienced Chemist to join our Melaka R&D team. The role focuses on analytical method development, validation, testing and documentation to support regulatory submissions.

You will contribute to GMP compliance, investigations, and method transfers from R&D to QC, helping ensure high-quality pharmaceuticals meet pharmacopoeial standards.

Qualifications

• Bachelor’s, Master’s or PhD in Pharmaceutical Science, Chemistry, Biochemistry or related discipline.
• Minimum 5 years of hands‑on experience in analytical method development, validation and analytical testing.
• Strong laboratory, data analysis and problem‑solving skills.
• Familiar with GMP, pharmacopoeial requirements and regulatory guidelines.

Responsibilities

• Conduct analytical method development, validation and troubleshooting activities.
• Execute raw material, in-process and finished product testing.
• Prepare and review analytical reports, protocols and investigation reports.
• Support regulatory submissions and respond to regulatory queries.
• Participate in OOS, OOT and laboratory investigations.
• Support method transfer activities from R&D to QC.
• Ensure compliance with GMP, pharmacopoeial requirements and regulatory guidelines.
• Support continuous improvement initiatives within the laboratory.

Skills

Analytical method development

Validation

Analytical testing

Data analysis

Problem solving

GMP knowledge

Education

Bachelor/Master/PhD in Pharmaceutical Science, Chemistry, Biochemistry

Job description

Kotra Pharma is seeking an experienced Chemist to join our R&D team in Melaka.

Key Responsibilities

• Conduct analytical method development, validation and troubleshooting activities.
• Execute raw material, in-process and finished product testing.
• Prepare and review analytical reports, protocols and investigation reports.
• Support regulatory submissions and respond to regulatory queries.
• Participate in OOS, OOT and laboratory investigations.
• Support method transfer activities from R&D to QC.
• Ensure compliance with GMP, pharmacopoeial requirements and regulatory guidelines.
• Support continuous improvement initiatives within the laboratory.

Requirements

• Bachelor’s Degree, Master’s Degree or PhD in Pharmaceutical Science, Chemistry, Biochemistry or related discipline.
• Minimum 5 years of hands‑on experience in analytical method development, validation and analytical testing.
• Strong laboratory, data analysis and problem-solving skills.
• Familiar with GMP, pharmacopoeial requirements and regulatory guidelines.
• Experience in pharmaceutical manufacturing environment will be an added advantage.