Title: Machine Operator
Job Purpose:
To operate pharmaceutical packaging equipment safely and efficiently while following cGMP, approved procedures and batch documentation requirements. The Packaging Operator ensures that products are correctly packed, coded and labelled, performs in-process checks and material reconciliation, and prevents contamination, mix-ups and documentation errors.
Job Responsibilities:
- Operate assigned primary and/or secondary packaging equipment in accordance with approved SOPs, packaging instructions and batch packaging records.
- Perform equipment and room checks before startup and support documented line clearance to confirm the area is clean and free from previous products, materials, labels and documents.
- Verify the product name, strength, batch number, expiry date, packaging materials, labels and quantities before and during packaging operations.
- Carry out equipment setup, startup, routine operation, cleaning and basic changeover activities within the operator’s authorization and training.
- Perform and record in-process checks, including pack appearance, completeness, coding/overprinting, label correctness, seal integrity, count and operation of line-monitoring devices.
- Continuously monitor the packaging line to prevent product mix-ups, contamination, mislabelling and damage.
- Complete batch records, equipment logs, cleaning records and production documentation accurately and at the time each activity is performed, following GDP and data-integrity requirements.
- Reconcile bulk product, printed packaging materials, labels and finished units; report all discrepancies immediately.
- Segregate and identify rejected, damaged or excess materials according to procedure and support documented destruction or return activities.
- Immediately report deviations, equipment faults, safety concerns and quality issues to the Supervisor, and assist with investigations when required.
- Meet approved production targets while maintaining product quality, safety and GMP compliance.
- Follow gowning, personal hygiene, environmental, health and safety requirements at all times.
- Maintain the work area in a clean and orderly condition and support 5S and continuous-improvement activities.
- Participate in required GMP, SOP, safety and equipment training and maintain qualification for assigned operations.
- Perform other packaging-related duties assigned by the Supervisor within the employee’s training and authorization.
Qualifications and Experience:
- Higher Secondary School certificate, technical diploma or equivalent; a relevant technical qualification is preferred.
- At least 1–2 years of packaging or production experience in a pharmaceutical, medical-device, food or other regulated manufacturing environment; pharmaceutical experience is preferred.
- Basic understanding of GMP, SOPs, good documentation practices and workplace safety.
- Ability to read and follow packaging instructions, labels, batch records and equipment procedures.
- Basic English reading, writing and communication skills.