The Machine Operator is responsible for operating, monitoring, and maintaining pharmaceutical manufacturing machines (e.g., tablet compression, capsule filling, blister packing, coating, granulation). The role ensures that products are manufactured in compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements (FDA, WHO, EMA, etc.).
Key Responsibilities
1. Machine Operation
Set up, start, operate, and shut down pharmaceutical production machines.
Monitor machine parameters and adjust settings to maintain efficiency and quality.
Load raw materials and ensure correct use of batch records.
Collect, count, and transfer finished products safely.
2. Compliance & Documentation
Follow cGMP, SOPs, and safety protocols at all times.
Complete logbooks, batch manufacturing records (BMRs), and other documentation accurately and in real time.
Report deviations, incidents, and non-conformities immediately.
3. Quality Assurance
Conduct in-process checks (weight variation, hardness, thickness, packaging integrity, etc.) as per defined standards.
Segregate and label rejected materials/products.
Maintain high standards of product quality and minimize production waste.
4. Maintenance & Housekeeping
Perform routine cleaning and basic maintenance of machines.
Ensure equipment is calibrated and in validated condition before use.
Maintain a clean and hygienic working area to prevent contamination.
5. Health, Safety, and Environment (HSE)
Wear required Personal Protective Equipment (PPE) (gloves, masks, gowns, goggles, etc.).
Follow safety guidelines for handling chemicals and pharmaceutical ingredients.
Report unsafe practices or hazards promptly.
6. Teamwork & Continuous Improvement
Coordinate with QA, engineering, and warehouse teams for smooth workflow.
Support new operator training and skill development.
Suggest improvements in machine operation, productivity, and safety.
