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.