Process Operator

Job Function:

• Operate, monitor, and control API manufacturing processes in accordance with approved Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and production schedules.
• Monitor execution of production plans and take timely corrective actions, including implementation of contingency measures to minimize downtime and ensure continuity.
• Control and adjust critical process parameters such as temperature, pressure, flow rates, and reaction conditions to maintain product quality and process efficiency.
• Take full ownership of batch processes on a day-to-day basis as directed by the Team Leader or Supervisor.
• Ensure strict adherence to current Good Manufacturing Practices (cGMP) and maintain the production area in a constant state of inspection readiness.
• Accurately complete, review, and maintain Batch Production Records (BPRs) and all supporting documentation in line with Good Documentation Practices (GDP).
• Verify and review documentation at the end of each shift to ensure accuracy, completeness, and compliance with regulatory requirements.
• Follow all instructions from the Team Leader or Supervisor and communicate effectively regarding production status and any deviations.
• Conduct routine equipment and process inspections to identify deviations, abnormalities, or potential risks.
• Proactively report equipment malfunctions, process deviations, and safety concerns, and assist with basic troubleshooting activities.
• Collaborate with maintenance, quality assurance, and engineering teams to resolve technical issues and improve operational performance.
• Participate in plant start-ups, shutdowns, cleaning, and changeover activities in accordance with validated procedures.
• Maintain a thorough understanding of all API batch processes, including chemical reactions, material handling, and critical process steps.
• Ensure full compliance with Occupational Health, Safety, and Environmental (OHSE) standards, including safe handling of hazardous chemicals and waste disposal procedures.