Reports To: Packaging Supervisor / Production Manager
Job Summary
- The Blistering Machine Operator is responsible for operating, setting up, monitoring, and maintaining blister packaging machines to ensure pharmaceutical products are packaged accurately, efficiently, and in compliance with Good Manufacturing Practices GMP, Standard Operating Procedures SOPs, and company quality standards.
- The operator ensures product integrity, minimizes downtime, and maintains accurate production documentation.
Key Responsibilities
- Set up, operate, and adjust blister packaging machines according to production schedules and batch manufacturing records.
- Verify packaging materials, including PVC, aluminum foil, cartons, leaflets, and labels, before production.
- Perform line clearance before and after production to prevent product mix-ups and cross-contamination.
- Conduct machine start-up, in-process checks, and shutdown procedures in accordance with SOPs.
- Monitor machine performance and make necessary adjustments to maintain optimal operating efficiency.
- Inspect blister packs for defects such as missing tablets, damaged blisters, incorrect sealing, printing errors, and coding issues.
- Record production data, equipment parameters, downtime, rejects, and material usage accurately.
- Ensure products are packaged according to approved specifications and regulatory requirements.
- Perform routine cleaning, lubrication, and minor preventive maintenance of blistering equipment.
- Report equipment malfunctions, deviations, or quality issues promptly to supervisors and maintenance personnel.
- Minimize material waste while maximizing production efficiency.
- Follow GMP, safety regulations, hygiene requirements, and company policies at all times.
- Participate in validation activities, equipment qualification, and process improvement initiatives when required.
- Assist during internal, customer, and regulatory audits.
- Maintain a clean and organized work environment following 5S principles.
Key Performance Indicators KPIs
- Production output achieved versus target
- Packaging quality and defect rate
- Machine uptime and operating efficiency
- Downtime reduction
- Material waste percentage
- Compliance with GMP and SOP requirements
- Accuracy and completeness of production documentation
- Safety and housekeeping compliance.
Qualifications
- High school diploma, technical certificate, or equivalent qualification; diploma in Engineering, Industrial Technology, or related field is an advantage.
- Previous experience operating blister packaging machines in a pharmaceutical, food, or FMCG manufacturing environment is preferred.
- Knowledge of pharmaceutical packaging processes and GMP requirements.
- Ability to read and understand batch records, SOPs, and packaging specifications.
- Basic mechanical troubleshooting skills.
- Good numerical and documentation skills.
- Ability to work rotating shifts, weekends, and overtime when required.
Required Skills:
- Blister machine setup and operation
- Equipment troubleshooting
- Attention to detail
- GMP and GDP compliance
- Documentation accuracy
- Quality inspection
- Teamwork and communication
- Time management
- Problem-solving
- Safety awareness
Physical Requirements:
- Ability to stand and walk for long periods.
- Good manual dexterity and hand-eye coordination.
- Ability to lift materials in accordance with company safety guidelines.
- Normal or corrected vision sufficient to detect packaging defects.
- Ability to work in a cleanroom environment while wearing appropriate PPE.
Working Conditions:
- Manufacturing and pharmaceutical packaging environment.
- Requires standing for extended periods.
- May involve lifting packaging materials within approved safety limits.
- Use of personal protective equipment PPE is mandatory.
- Work is performed in controlled cleanroom or packaging areas with strict hygiene requirements.
