Production Supervisor - GMP and ISO Compliance

Overview

This role oversees the production operations at a pharmaceutical facility, ensuring strict adherence to GMP, ISO 9001:2015, ISO 13485:2016, and ISO 15378:2017 standards. The supervisor ensures accurate documentation, team development, production quality, and compliance monitoring.

Key Responsibilities

• Oversee completion and accuracy of production and batch records, ensuring errors are investigated and documents are authorized properly.
• Maintain records following approved protocols and regulatory standards.
• Promptly report and engage in resolution of deviations, non-compliances, and change control requests.
• Create and update procedural documents governing production activities.
• Implement and ensure adherence to production procedures and operational instructions.
• Conduct initial and ongoing training for production staff, managing performance evaluations per company procedures.
• Supervise production operations to confirm compliance with documented procedures and product quality requirements.
• Enforce rigorous plant hygiene protocols among production and control personnel.
• Manage repacking processes and review related reports.
• Monitor production operations continuously to maintain control over processes.
• Ensure proper weighing and measurement of materials into clean, labeled containers.
• Verify integrity of sterilized filters using appropriate validation tests before and after use.
• Authorize use of printed packaging materials according to approved guidelines.
• Oversee sampling, inspection, and investigation activities ensuring product quality.
• Monitor compliance with GMP and relevant ISO standards.
• Conduct regular self-inspections for GMP adherence and suggest corrective actions when necessary.
• Coordinate with maintenance to minimize production interruptions.
• Ensure calibration, qualification, and maintenance of equipment and premises.
• Confirm cleanliness of premises before processing or packaging, preventing cross-contamination.
• Maintain cleaning and storage standards of manufacturing equipment as per written procedures.
• Manage machine logbooks, ensuring all activities are duly recorded.
• Participate in quality performance reporting and identify improvement opportunities.
• Contribute to management reviews addressing process performance and quality system enhancements.
• Meet production schedules while maintaining required product quality.
• Adjust resource allocation to optimize production planning implementation.
• Maintain effective communication channels to escalate quality concerns timely within management hierarchy.