Location: Klang, Selangor
Company: Duopharma (M) Sdn Bhd
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
Validation, Qualification & Technology Transfer
- 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
Continuous Improvement
- 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
Competencies
- 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
