Manufacturing QA & Process Leader (Biopharma)

Biocon Sdn Bhd; Johor Bahru; On-site; MYR 180,000 - 240,000; Full time

Job summary

Biocon Sdn Bhd in Malaysia seeks an Assistant Manager to lead Manufacturing QA, focusing on process validation and Drug Substance operations. You will oversee upstream/fermentation and downstream purification, ensuring compliance with QA standards and regulatory expectations.

The role involves reviewing batch records, deviations, investigations, CAPAs and change controls, supporting batch disposition, and driving QMS improvements.

Qualifications

• 6–10 years in Biopharma Manufacturing QA
• Preferably Drug Substance operations
• Experience with deviations, investigations and change controls

Responsibilities

• QA oversight of process validation and Drug Substance manufacturing.
• Oversee upstream/fermentation and downstream/purification processes.
• Review batch records, deviations, investigations, CAPAs and change controls.
• Support batch disposition and manufacturing QMS.
• Assist audit/inspection readiness and quality improvement activities.

Skills

QA oversight

Process validation

Batch records

CAPA & deviations

Job description

Biocon Sdn Bhd in Malaysia seeks an Assistant Manager to lead Manufacturing QA, focusing on process validation and Drug Substance operations. You will oversee upstream/fermentation and downstream purification, ensuring compliance with QA standards and regulatory expectations.

The role involves reviewing batch records, deviations, investigations, CAPAs and change controls, supporting batch disposition, and driving QMS improvements.