Job Description

Job Summary: The SPM Operator is responsible for the operation and maintenance of Solid Preparation Machines (SPM) used in the production of pharmaceutical products. This role involves ensuring efficient and accurate processing, adhering to quality standards, and complying with regulatory requirements.Key Responsibilities:Operation of SPM Equipment:

• Operate Solid Preparation Machines (SPM), including granulators, mixers, mills, and tablet presses, according to production specifications and batch records.
• Set up machines for production runs, including loading raw materials, calibrating equipment, and adjusting machine settings.
• Monitor machine operations to detect malfunctions or deviations from specifications and make necessary adjustments.

Quality Control:

• Follow Good Manufacturing Practices (GMP) and standard operating procedures (SOPs) to ensure the quality and safety of products.
• Conduct in-process checks and inspections to ensure that products meet specified quality standards.
• Document and report any quality issues to the Production Supervisor or Quality Assurance team.

Maintenance and Troubleshooting:

• Perform routine maintenance on SPM 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 preventative maintenance activities.

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.

Safety and Compliance:

• Adhere to 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.

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 pharmaceutical manufacturing processes is preferred.
• Experience: Previous experience operating Solid Preparation Machines (SPM) or similar equipment in a pharmaceutical or related manufacturing environment is highly desirable.
• Skills:

• Knowledge of SPM 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.

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