Sterile Injectable Ops Leader - Aseptic & Compliance

Duopharma Biotech Bhd Group of Companies.; George Town; On-site; MYR 60,000 - 90,000; Full time

Job summary

Duopharma Biotech Bhd Group of Companies. is seeking an Executive for Sterile Aseptic Operations & Process Integrity in Penang. The role focuses on maintaining aseptic manufacturing standards, GMP compliance and on-floor process oversight in a 24/7 shift environment.

You will support audits, drive compliance initiatives and participate in the Sterile Master Plan expansion project, contributing to technology transfer and validated production practices.

Qualifications

• Bachelor's Degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, or related science discipline.
• Minimum 2–3 years hands-on experience in aseptic processing or sterile pharmaceutical manufacturing environments.

Responsibilities

• Aseptic Operations & Process Integrity: ensure GMP/EU GMP Annex 1 compliance and aseptic manufacturing standards.
• Production Supervision: supervise shifts, monitor equipment readiness and environmental conditions, ensure safe, efficient production.
• Documentation & Compliance: ensure accurate batch records, GDP and data integrity, support investigations and audits.
• Aseptic Behavior & Competency Development: enforce gowning and cleanroom discipline, train staff, support continuous improvement.
• Assist in equipment qualification, validation activities (IQ/OQ/PQ) and technology transfer.

Skills

Aseptic techniques

GMP compliance

Process parameter monitoring

IQ/OQ/PQ familiarity

Technology transfer

24/7 operations

Attention to detail

Communication skills

Independent decision-making

Problem solving

Education

Bachelor's degree in pharmaceutical sciences or related

Job description

Duopharma Biotech Bhd Group of Companies. is seeking an Executive for Sterile Aseptic Operations & Process Integrity in Penang. The role focuses on maintaining aseptic manufacturing standards, GMP compliance and on-floor process oversight in a 24/7 shift environment.

You will support audits, drive compliance initiatives and participate in the Sterile Master Plan expansion project, contributing to technology transfer and validated production practices.