Biosimilar Process & Quality Associate

Ain Medicare Sdn Bhd; Kota Bharu; On-site; MYR 60,000 - 90,000; Full time

Job summary

AIN MEDICARE SDN. BHD. in Malaysia is seeking a dedicated professional to support biosimilar product development, manufacturing, and process improvement within GMP-compliant systems.

The role involves preparing technical documentation, coordinating with cross-functional teams, and monitoring process performance to ensure quality timelines. The ideal candidate holds a Bachelor's degree in Biotechnology or related fields and has 2–5 years' experience in pharma/biotech.

Qualifications

• Bachelor's degree in biotechnology or related field.
• 2–5 years of pharma/biotech/biosimilar experience.
• Knowledge of GMP, regulatory requirements, quality systems.
• Strong analytical, documentation, communication, and problem-solving abilities.

Responsibilities

• Support biosimilar product development, manufacturing, and process improvement activities
• Support quality activities in GMP/regulatory compliance
• Prepare and maintain technical documentation
• Coordinate with cross-functional teams
• Monitor process and product performance
• Support investigations and CAPA; ensure timelines

Skills

Analytical skills

Documentation

Communication skills

Problem-solving

Education

Bachelor's Degree in Biotechnology, Biochemistry, Bioprocess Engineering, Microbiology, or a related field

Job description

AIN MEDICARE SDN. BHD. in Malaysia is seeking a dedicated professional to support biosimilar product development, manufacturing, and process improvement within GMP-compliant systems.

The role involves preparing technical documentation, coordinating with cross-functional teams, and monitoring process performance to ensure quality timelines. The ideal candidate holds a Bachelor's degree in Biotechnology or related fields and has 2–5 years' experience in pharma/biotech.