- Setup and operate pharmaceutical production equipment, including high-speed filling lines for sterile products, autoclave, parts and vial washers, depyrogenation tunnel, formulation process, HMI and automatic CIP/SIP processes, and inspection and packaging line equipment (e.g., AVIM, labeling, and carton machine), as per relevant SOPs and Batch Record.
- Complete formulation activities for production batches, including the formulation and/or dispensing of all available drug substance(s) and excipients.
- Prepare, wash, and sterilize materials and parts.
- Handle the packaging and transfer of final products to the freezer.
- Complete all necessary training prior to task execution.
- Perform all material and process (SAP) transactions at each manufacturing step.
- Adhere closely to aseptic techniques and practices for aseptic operations.
- Maintain and clean production equipment and classified areas.
- Conduct routine QC sampling and in-process testing of the product at various manufacturing stages.
- Timely completion of batch records and logbooks in adherence to GDP.
- Transfer materials for batch manufacturing.
- Prepare filters for test execution and perform FIT (Filter Integrity Testing).
- Load and unload equipment during production activities.
- Monitor stock levels of consumables and inform the Manager/Lead technician of material requirements.
- Ensure safety and quality compliance at all times and report any anomalies to the Manager promptly.
- Participate in EHS, Business Compliance, cGMP, and other compliance-related activities.
- Report all quality issues immediately to the Manager or Lead technician.
- Perform microbial sampling and swabbing of room and equipment if required.
- Liaise with external vendors for instrument calibration and maintenance.
- Conduct chemical and mathematical calculations to resolve product potency and endotoxin levels if necessary.
- Inspect, label, and package finished drug products and perform in-process sampling and inspections on semi-finished products.
- Undertake any other duties assigned by the Manager.
Education
- Minimum O Level, NITEC/ITE education/Diploma in a relevant field.
Experience
- 3 to 5 years of relevant experience in the pharmaceutical industry.
Knowledge, Skills, Abilities
- Good understanding of safe working practices and cGMP.
- Highly motivated to work in the pharmaceutical industry.
- Strong team-player with an ability to work rotating shifts.
