Production Supervisor (Autoclave & Manufacturing)

<div style="color:rgb(0,0,0);font-family:'Segoe UI';line-height:20px;"><p><strong><span style="font-family:Calibri;font-size:12px;">Department:</span></strong><span style="font-family:Calibri;font-size:12px;"> Production</span><br /><strong><span style="font-family:Calibri;font-size:12px;">Location:</span></strong><span style="font-family:Calibri;font-size:12px;"> Unit 09 Fill & Finish </span><br /><strong><span style="font-family:Calibri;font-size:12px;">Reports To:</span></strong><span style="font-family:Calibri;font-size:12px;"> Production Manager </span></p><p><span style="font-size:12px;font-family:Calibri;">Experience</span></p><div style="line-height:20px;"><ul><li><span style="font-family:Calibri;font-size:12px;">6-8 years of experience in injectable pharmaceutical manufacturing.</span></li><li><span style="font-family:Calibri;font-size:12px;">Minimum 4 years of supervisory experience in manufacturing and autoclave operations preferred.</span></li></ul><p><span style="font-size:12px;font-family:Calibri;">Education</span></p><ul><li><span style="font-family:Calibri;font-size:12px;">B.Pharm / M.Pharm / B.Sc / M.Sc </span></li></ul></div><h3><span style="font-family:Calibri;font-size:12px;">Job Purpose</span></h3><p><span style="font-family:Calibri;font-size:12px;">To supervise and coordinate daily manufacturing and sterilization activities in the injectable production area, ensuring compliance with cGMP, GDP, SOPs, safety standards, and regulatory requirements while achieving production targets and maintaining product quality.</span></p><p><br /></p><div style="line-height:20px;"><h2><span style="font-family:Calibri;font-size:12px;">Key Responsibilities</span></h2><h3><span style="font-family:Calibri;font-size:12px;">1. Manufacturing Operations</span></h3><ul><li><span style="font-family:Calibri;font-size:12px;">Supervise day-to-day manufacturing activities including preparation, compounding, filtration, and filling support operations.</span></li><li><span style="font-family:Calibri;font-size:12px;">Ensure adherence to approved Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs).</span></li><li><span style="font-family:Calibri;font-size:12px;">Monitor production schedules and ensure timely completion of batches.</span></li><li><span style="font-family:Calibri;font-size:12px;">Coordinate with Quality Assurance (QA), Quality Control (QC), Engineering, Warehouse, and Validation departments.</span></li><li><span style="font-family:Calibri;font-size:12px;">Ensure line clearance before commencement and after completion of manufacturing activities.</span></li><li><span style="font-family:Calibri;font-size:12px;">Verify material dispensing, usage, and reconciliation activities.</span></li></ul><div style="line-height:20px;"><h3><span style="font-family:Calibri;font-size:12px;">2. Autoclave Operations</span></h3><ul><li><span style="font-family:Calibri;font-size:12px;">Supervise loading, unloading, and operation of autoclaves for sterilization of equipment, garments, utensils, components, and accessories.</span></li><li><span style="font-family:Calibri;font-size:12px;">Ensure sterilization cycles are performed as per validated parameters.</span></li><li><span style="font-family:Calibri;font-size:12px;">Review autoclave cycle records, printouts, and sterilization documentation.</span></li><li><span style="font-family:Calibri;font-size:12px;">Ensure proper segregation and identification of sterilized and non-sterilized materials.</span></li><li><span style="font-family:Calibri;font-size:12px;">Coordinate for biological indicator and validation activities whenever required.</span></li><li><span style="font-family:Calibri;font-size:12px;">Monitor autoclave performance and report abnormalities immediately.</span></li></ul><p><br /></p><div style="line-height:20px;"><h3><span style="font-family:Calibri;font-size:12px;">3. GMP & Compliance</span></h3><ul><li><span style="font-family:Calibri;font-size:12px;">Ensure strict compliance with cGMP, Schedule M, EU GMP, WHO GMP, and data integrity requirements.</span></li><li><span style="font-family:Calibri;font-size:12px;">Maintain proper documentation and real-time recording practices.</span></li><li><span style="font-family:Calibri;font-size:12px;">Participate in internal audits, regulatory inspections, and customer audits.</span></li><li><span style="font-family:Calibri;font-size:12px;">Ensure closure of deviations, CAPA, change controls, and investigation actions assigned to the department.</span></li></ul><div style="line-height:20px;"><h3><span style="font-family:Calibri;font-size:12px;">4. Team Management</span></h3><ul><li><span style="font-family:Calibri;font-size:12px;">Allocate manpower efficiently to meet production requirements.</span></li><li><span style="font-family:Calibri;font-size:12px;">Train and guide operators on SOPs, GMP, safety, and operational excellence.</span></li><li><span style="font-family:Calibri;font-size:12px;">Conduct shift handovers and briefings.</span></li><li><span style="font-family:Calibri;font-size:12px;">Monitor discipline, attendance, and performance of production personnel.</span></li><li><span style="font-family:Calibri;font-size:12px;">Develop multiskilling and succession within the production team.</span></li></ul><div style="line-height:20px;"><h3><span style="font-family:Calibri;font-size:12px;">5. Documentation & Record Management</span></h3><ul><li><span style="font-family:Calibri;font-size:12px;">Review BMRs, logbooks, equipment records, and sterilization records.</span></li><li><span style="font-family:Calibri;font-size:12px;">Ensure completion and filing of production documents without errors.</span></li><li><span style="font-family:Calibri;font-size:12px;">Report and investigate any deviations or incidents occurring during operations.</span></li><li><span style="font-family:Calibri;font-size:12px;">Maintain equipment utilization and production efficiency records</span>.</li></ul></div></div></div></div><div style="line-height:20px;"><h3><br /></h3></div></div></div>