Drug Substance Production: GMP Ops Associate

Biocon Sdn Bhd; Johor Bahru; On-site; MYR 67,000 - 100,000; Full time

Job summary

Biocon Sdn Bhd in Malaysia seeks a biotech/pharma professional to monitor GMP compliance and ensure production instructions are followed. The role involves updating real-time data entries in BMRs and related documents and supporting qualification activities.

The successful candidate will hold a Bachelor's degree in biotechnology or chemical engineering, with 1–4 years of hands-on experience in Drug Substance manufacturing or similar operations, and participate in mandatory cGMP training annually.

Qualifications

• 1-4 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Must be familiar with cGMP, GDP, DI, GLP and training requirements.

Responsibilities

• Monitor compliance with Good Manufacturing Practice (GMP).
• Ensure production instructions are followed.
• Update real-time data entries in DSP2 (BMRs, CKL, LS, ECC).
• Execute equipment qualification and validation protocols.
• Maintain production equipment in coordination with maintenance.
• Comply with EHS policies and procedures.
• Responsible for OTIF execution of Downstream Purification-2 activities.
• Data owner for process equipment.

Skills

GxP training

cGMP knowledge

Data integrity

Documentation

Education

Bachelor's degree in biotechnology or chemical engineering

Job description

Biocon Sdn Bhd in Malaysia seeks a biotech/pharma professional to monitor GMP compliance and ensure production instructions are followed. The role involves updating real-time data entries in BMRs and related documents and supporting qualification activities.

The successful candidate will hold a Bachelor's degree in biotechnology or chemical engineering, with 1–4 years of hands-on experience in Drug Substance manufacturing or similar operations, and participate in mandatory cGMP training annually.