Downstream Drug Substance Associate — GMP Focus

Biocon; Johor Bahru; On-site; MYR 45,000 - 67,000; Full time

Job summary

Biocon Biologics, a global biopharmaceutical leader and subsidiary of Biocon Ltd, is seeking a Production Associate to monitor GMP compliance and ensure production instructions are strictly followed at its Johor Bahru site.

The role involves updating real-time data in DSP and CKL systems, executing qualification and validation protocols, maintaining equipment, and ensuring safe, efficient downstream operations in a cGMP environment.

Qualifications

• Bachelor in Chemical engineering or related.
• Good in soft skill such as communication and teamwork.
• Good in problem solving and decision making.

Responsibilities

• Monitor compliance with Good Manufacturing Practice requirements.
• Ensure production instructions are strictly followed.
• Update real time data entry in DSP, CKL, LS, ECC and other documents.
• Execute equipment qualification and validation protocols.
• Knowledgeable in GMP system, GDP and DI.
• Perform and document operations in accordance with cGMP.
• Maintenance of production equipment in coordination with maintenance department.
• Comply with EHS policies and procedures.
• Responsible for OTIF execution of all activities related to Downstream.

Skills

Communication

Teamwork

Problem solving

Education

Bachelor in Chemical engineering or related

Job description

Biocon Biologics, a global biopharmaceutical leader and subsidiary of Biocon Ltd, is seeking a Production Associate to monitor GMP compliance and ensure production instructions are strictly followed at its Johor Bahru site.

The role involves updating real-time data in DSP and CKL systems, executing qualification and validation protocols, maintaining equipment, and ensuring safe, efficient downstream operations in a cGMP environment.