Pharma PQI & Process Optimization Lead

Duopharma Biotech Bhd Group of Companies.; Bandar Baru Bangi; On-site; MYR 54,000 - 78,000; Full time

Job summary

Duopharma Biotech Berhad is seeking a qualified professional to manage and execute trials for product quality improvement projects in formulation, process improvements, and analytical test procedures where applicable.

The role involves evaluating alternative materials for suitability and supporting the transfer of new products from R&D to manufacturing sites. Relevant in-house analytics and documentation will be part of daily duties.

Qualifications

• Bachelor's degree in Life Science required.
• Master's degree in pharmaceutical sciences or chemistry is an advantage.
• 1–4 years of pharmaceutical experience preferred.

Responsibilities

• Execute formulation trials for product quality improvement and alternative/new materials evaluation.
• Review trial results and update project progress status in a timely manner.
• Prepare technical documents required by RA/QA and other departments with traceability of experiment/test data.
• Assist in the functional evaluation of alternative/new material sources, including trial batch manufacturing for stability or registration.
• Support manufacturing scale-up and transfer from R&D to production or change of site.
• Assist in analytical method troubleshooting and testing of PQI samples.
• Author key documents and reports (design review documents, trial batch review report, trial result summary).
• Any other assignments as they arise.

Education

Bachelor's degree in Life Science

Master's degree in Pharmaceutical Sciences / Chemistry

Job description

Duopharma Biotech Berhad is seeking a qualified professional to manage and execute trials for product quality improvement projects in formulation, process improvements, and analytical test procedures where applicable.

The role involves evaluating alternative materials for suitability and supporting the transfer of new products from R&D to manufacturing sites. Relevant in-house analytics and documentation will be part of daily duties.