Production Supervisor (Autoclave & Manufacturing)

Department: Production
Location: Unit 09 Fill & Finish
Reports To: Production Manager
Experience
6-8 years of experience in injectable pharmaceutical manufacturing.
Minimum 4 years of supervisory experience in manufacturing and autoclave operations preferred.
Education
B.Pharm / M.Pharm / B.Sc / M.Sc
Job Purpose
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.
Key Responsibilities1. Manufacturing Operations
Supervise day-to-day manufacturing activities including preparation, compounding, filtration, and filling support operations.
Ensure adherence to approved Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs).
Monitor production schedules and ensure timely completion of batches.
Coordinate with Quality Assurance (QA), Quality Control (QC), Engineering, Warehouse, and Validation departments.
Ensure line clearance before commencement and after completion of manufacturing activities.
Verify material dispensing, usage, and reconciliation activities.
2. Autoclave Operations
Supervise loading, unloading, and operation of autoclaves for sterilization of equipment, garments, utensils, components, and accessories.
Ensure sterilization cycles are performed as per validated parameters.
Review autoclave cycle records, printouts, and sterilization documentation.
Ensure proper segregation and identification of sterilized and non-sterilized materials.
Coordinate for biological indicator and validation activities whenever required.
Monitor autoclave performance and report abnormalities immediately.
3. GMP & Compliance
Ensure strict compliance with cGMP, Schedule M, EU GMP, WHO GMP, and data integrity requirements.
Maintain proper documentation and real-time recording practices.
Participate in internal audits, regulatory inspections, and customer audits.
Ensure closure of deviations, CAPA, change controls, and investigation actions assigned to the department.
4. Team Management
Allocate manpower efficiently to meet production requirements.
Train and guide operators on SOPs, GMP, safety, and operational excellence.
Conduct shift handovers and briefings.
Monitor discipline, attendance, and performance of production personnel.
Develop multiskilling and succession within the production team.
5. Documentation & Record Management
Review BMRs, logbooks, equipment records, and sterilization records.
Ensure completion and filing of production documents without errors.
Report and investigate any deviations or incidents occurring during operations.
Maintain equipment utilization and production efficiency records.

Employment type
C-C8-Confirmed-HO Executive

Work arrangement
No