R&D Quality Lead: Analytical Lab & Tech Transfer

Duopharma Biotech; Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

Duopharma Innovation Sdn Bhd is seeking an experienced Assistant Manager/Senior Executive for R&D Quality Management to lead analytical laboratory activities and ensure compliance with GMP, GLP, ISO standards, and regulatory requirements.

The role involves overseeing analysts, supporting pilot batches, process validation, method transfer, documentation review, and contributing to quality systems for pharmaceutical product development and regulatory submissions.

Qualifications

• Bachelor's degree in relevant scientific discipline.
• 5+ years for Senior Executive; 10+ years for Assistant Manager.
• Experience in regulated pharmaceutical labs, R&D QC, and analytical testing.

Responsibilities

• Coordinate daily analytical laboratory activities, projects and personnel.
• Support regulatory submissions and quality management activities.
• Ensure GMP, GLP, ISO 9001, ISO 13485, ISO/IEC 17025 compliance.
• Oversee method transfer, technology transfer, and documentation review.

Skills

Analytical testing

Quality management

Laboratory leadership

Regulatory knowledge

Project management

Education

Bachelor's degree in Biotechnology, Pharmaceutical Science, Chemistry, Analytical Science, or related

Tools

Analytical instruments

Job description

Duopharma Innovation Sdn Bhd is seeking an experienced Assistant Manager/Senior Executive for R&D Quality Management to lead analytical laboratory activities and ensure compliance with GMP, GLP, ISO standards, and regulatory requirements.

The role involves overseeing analysts, supporting pilot batches, process validation, method transfer, documentation review, and contributing to quality systems for pharmaceutical product development and regulatory submissions.