Executive, Sterile Injectable Pharmaceutical Manufacturing

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

Executive, Sterile Injectable Pharmaceutical Manufacturing

Executive, Sterile Aseptic Operations & Process Integrity (Sterile Pharmaceutical Manufacturing)

Job Summary

This role is responsible for maintaining process integrity, GMP compliance, and aseptic manufacturing standards within a sterile pharmaceutical production environment. Working on a 24/7 shift rotation, you will oversee critical manufacturing processes, support audit readiness, drive compliance initiatives, and contribute to the successful implementation of Duopharma's Sterile Master Plan expansion project.

Key Responsibilities

Aseptic Operations & Process Integrity

Ensure strict compliance with GMP, EU GMP Annex 1 requirements, and aseptic manufacturing standards

Monitor critical production activities to maintain sterility assurance and minimize contamination risks

Provide on-floor process oversight across sterile manufacturing operations

Ensure adherence to validated procedures, batch documentation, and quality requirements throughout production activities

Production Supervision

Support continuous manufacturing operations through effective shift supervision

Monitor equipment readiness, environmental conditions, and operator practices

Ensure production schedules are executed safely, efficiently, and in accordance with approved procedures

Escalate operational issues and support timely resolution to prevent disruptions to manufacturing activities

Documentation & Compliance

Ensure accurate completion and review of batch records, logbooks, and production documentation

Promote Good Documentation Practices (GDP) and data integrity principles

Support investigations related to deviations, incidents, CAPAs, and non-conformances

Assist in audit preparation and regulatory inspection readiness activities

Aseptic Behavior & Competency Development

Monitor compliance with aseptic gowning practices and cleanroom behavior requirements

Identify performance gaps and support corrective actions

Assist in training and competency development programs for manufacturing personnel

Reinforce contamination control strategies and aseptic discipline on the production floor

Support equipment qualification and validation activities, including IQ, OQ, and PQ execution

Participate in technology transfer and product transfer projects

Assist in SOP development, review, and continuous improvement initiatives

Support readiness activities for new sterile manufacturing facilities and expansion projects

Participate in operational excellence initiatives, including Gemba walks and process improvement projects

Identify opportunities to improve efficiency, compliance, and process robustness

Recommend improvements to procedures, controls, and manufacturing practices

Requirements

Qualifications

Bachelor's Degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, or related science discipline

Experience

Minimum 2–3 years of hands-on experience in aseptic processing or sterile pharmaceutical manufacturing environments

Technical Skills & Knowledge

Strong understanding of sterile manufacturing processes and aseptic techniques

Knowledge of GMP, EU GMP Annex 1, and pharmaceutical regulatory requirements

Experience monitoring critical process parameters and production controls

Familiarity with equipment qualification and validation activities (IQ/OQ/PQ)

Understanding of technology transfer and process adaptation activities

Ability to work effectively in a 24/7 manufacturing environment

Strong attention to detail and compliance mindset

Excellent communication and teamwork skills

Ability to work independently and make sound operational decisions

Strong problem-solving and analytical abilities

Resilient and adaptable in a fast-paced, highly regulated environment

Proactive approach to continuous improvement and operational excellence

Why Join Us

Be part of a major sterile manufacturing expansion project

Gain exposure to advanced aseptic processing and Annex 1 compliance requirements

Participate in qualification, validation, and technology transfer activities

Develop expertise in one of the pharmaceutical industry's most specialized manufacturing environments

Strong career progression opportunities within sterile operations and manufacturing leadership