GRANULATION OPERATOR

Job Description:

Job Summary: The Granulation Operator is responsible for the granulation process in the production of pharmaceutical products. This role involves operating granulation equipment, following batch records, and ensuring that products meet quality standards and regulatory requirements.

Key Responsibilities:

1. Operation of Granulation Equipment:

   • Operate and monitor granulation machinery, including mixers, mills, and dryers, to produce granulated pharmaceutical products according to production specifications and batch records.
   • Set up equipment for production runs, including the adjustment of machine settings and loading of materials.
   • Perform in-process checks to ensure that granules meet specified quality standards.

2. Quality Control:

   • Adhere to Good Manufacturing Practices (GMP) and standard operating procedures (SOPs) to ensure the quality and safety of granulated products.
   • Conduct visual and physical inspections of granules during and after production to detect defects or inconsistencies.
   • Document and report any quality issues to the Production Supervisor or Quality Assurance team.

3. Maintenance and Troubleshooting:

   • Conduct routine maintenance on granulation equipment to ensure optimal performance and minimize downtime.
   • Troubleshoot mechanical issues and perform minor repairs as needed.
   • Coordinate with maintenance personnel for major repairs and maintenance activities.

4. Documentation and Reporting:

   • Maintain detailed and accurate production logs, including batch records, machine settings, and maintenance activities.
   • Prepare reports on production output, machine performance, and quality control results.
   • Ensure all documentation is completed in compliance with regulatory and company requirements.

5. Safety and Compliance:

   • Follow all safety protocols and procedures to maintain a safe working environment.
   • Participate in safety training programs and report any safety hazards or incidents.
   • Ensure compliance with local, state, and federal regulations, as well as company policies.

6. Team Collaboration:

   • Work closely with other production staff, quality assurance, and maintenance personnel to ensure efficient and smooth operations.
   • Participate in team meetings and contribute to continuous improvement initiatives.
   • Provide training and guidance to new operators and assist with cross-training initiatives.

Qualifications:

• Education: High school diploma or equivalent. Technical training or certification in machine operation or manufacturing processes is preferred.
• Experience: Previous experience in granulation or a similar role within the pharmaceutical or related manufacturing industry is highly desirable.
• Skills:
  • Knowledge of granulation processes and equipment.
  • Mechanical aptitude and troubleshooting skills.
  • Attention to detail and commitment to quality.
  • Basic computer skills for data entry and report generation.
  • Good communication and teamwork abilities.
• Physical Requirements: Ability to stand for extended periods, lift heavy objects, and perform repetitive tasks. Must be able to work in a manufacturing environment with varying temperatures and noise levels.
• Certifications: Certification in Good Manufacturing Practices (GMP) or other relevant industry certifications is advantageous.

Work Schedule:

• Full-time position with rotating shifts, including nights, weekends, and holidays as required.