Machine Operator

Job Overview

This role involves operating pharmaceutical packaging machinery in a safe and effective manner while adhering to current Good Manufacturing Practices (cGMP), approved protocols, and batch documentation standards. The Machine Operator is responsible for ensuring accurate packaging, proper coding and labeling of products, conducting in-process inspections, managing material reconciliation, and preventing contamination, errors, and mix-ups.

Key Responsibilities

• Operate primary and secondary packaging machines according to established Standard Operating Procedures (SOPs), packaging guidelines, and batch records.
• Conduct equipment and facility inspections prior to startup and assist with documented line clearance to ensure the area is free of previous products, labels, materials, and paperwork.
• Confirm product details including name, strength, batch number, expiry date, packaging components, labels, and quantities before and during packaging operations.
• Carry out setup, startup, routine operation, cleaning, and basic changeovers within authorized training limits.
• Perform and document in-process checks such as packaging appearance, completeness, coding accuracy, seal integrity, labeling correctness, product counts, and line-monitoring device functioning.
• Monitor packaging processes continually to avoid contamination, product mix-ups, mislabeling, and any damage.
• Complete batch production records, equipment logs, cleaning records, and other documentation precisely and contemporaneously, complying with Good Documentation Practices and data integrity standards.
• Reconcile bulk products, printed packaging materials, labels, and finished goods, immediately reporting any discrepancies.
• Isolate and identify rejected, damaged, or surplus materials as per procedure and assist in their destruction or return as required.
• Report deviations, mechanical faults, safety issues, and quality concerns promptly to the supervisor and provide support during investigations.
• Achieve designated production targets while ensuring product quality and adherence to safety and GMP standards.
• Consistently follow gowning, hygiene, environmental, health, and safety protocols.
• Maintain cleanliness and organization of the work area, contributing to 5S initiatives and continuous improvements.
• Participate actively in mandatory GMP, SOP, safety, and equipment training, maintaining qualification for operational tasks assigned.
• Perform additional packaging-related responsibilities as assigned within authorized training scope.

Qualifications and Experience

• Higher Secondary School certificate, technical diploma, or equivalent, with preference for relevant technical qualifications.
• Minimum 1 to 2 years of experience in packaging or production within pharmaceutical, medical device, food, or other regulated manufacturing environments; pharmaceutical background preferred.
• Fundamental knowledge of GMP, SOPs, documentation practices, and workplace safety.
• Ability to interpret packaging instructions, batch records, labels, and equipment procedures.
• Basic proficiency in English reading, writing, and verbal communication.