The Production Supervisor is responsible for overseeing day-to-day manufacturing
operations to ensure the safe, efficient, and compliant production of sterile injectable
pharmaceutical products. The role supervises production personnel, coordinates
manufacturing activities, ensures adherence to cGMP and aseptic practices, and supports
the achievement of production schedules while maintaining the highest standards of
product quality, safety, and regulatory compliance.
Key Responsibilities
Provide hands-on supervision on the manufacturing floor, working alongside
production personnel to operate, monitor, troubleshoot, and optimize sterile
manufacturing equipment while ensuring production targets, product quality, and
regulatory compliance are achieved.
Act as the first line of support for operators by providing technical guidance, resolving
production issues, and ensuring manufacturing activities are executed safely and
efficiently.
Supervise and provide hands-on support for sterile injectable manufacturing
operations, including compounding, aseptic filling, capping, vial washing,
depyrogenation, isolator operations, lyophilization, terminal sterilization, and
autoclave processes.
Ensure proper execution of aseptic manufacturing practices, equipment assembly,
machine setup, line clearance, changeovers, cleaning, and basic troubleshooting in
ISO-classified cleanroom environments.
Lead and support Process Qualification (PQ), media fills, smoke studies,
validation batches, equipment qualification, and autoclave/VHP cycle
qualification activities in collaboration with Validation and Quality teams.
Ensure manufacturing activities are performed in accordance with approved SOPs,
Batch Manufacturing Records (BMRs), cGMP requirements, and Good
Documentation Practices (GDP).
Review production documentation for completeness and accuracy, ensuring timely
completion of batch records and manufacturing logs.
Monitor adherence to cleanroom behavior, contamination control practices,
gowning procedures, environmental requirements, and safety standards.
Identify, investigate, and document deviations, equipment malfunctions, and non conformances, and support root cause analysis, CAPA implementation, and
continuous improvement initiatives.
Coordinate with Engineering and Maintenance to ensure equipment calibration,
preventive maintenance, and maximum equipment uptime.
Support regulatory inspections, customer audits, and validation activities by
maintaining an inspection-ready manufacturing environment at all times.Perform
other duties as assigned.
Qualifications
Bachelor's degree in Pharmacy, Chemical Engineering, Mechanical Engineering,
Biotechnology, Industrial Engineering, or a related scientific discipline.
Minimum 5–8 years of pharmaceutical manufacturing experience, with at least 2–3
years in a supervisory role.
Mandatory experience in sterile injectable pharmaceutical manufacturing.
Hands-on experience operating and supervising sterile injectable manufacturing
equipment, including Isolators, Lyophilizers, Rotary Vial Washers, Depyrogenation
Tunnels, Filling & Capping Machines, Autoclaves, VHP Systems, and Compounding
Equipment.
Strong understanding of aseptic processing, cleanroom operations, and
manufacturing documentation.
Experience leading production teams in a cGMP-regulated environment.
Excellent leadership, communication, problem-solving, and organizational skills.
Technical Knowledge
Current Good Manufacturing Practices (cGMP) and US FDA 21 CFR Parts 210 & 211
Aseptic processing and sterile manufacturing operations
Batch Manufacturing Records (BMRs) and Good Documentation Practices (GDP)
Equipment operation, cleaning, line clearance, and changeover procedures
Deviation investigations, CAPA, Change Control, and Quality Risk Management (ICH
Q9)
Data Integrity (ALCOA+) principles
Lean Manufacturing and Continuous Improvement methodologies
Environmental Health & Safety (EHS) and cleanroom behavior requirements
Key Performance Indicators (KPIs)
Achievement of daily and weekly production schedules
Manufacturing Right First Time (RFT) and batch yield
On-time batch completion and documentation review
Reduction in production deviations and repeat errors
CAPA implementation and closure within established timelines
Compliance with cGMP, SOPs, and safety requirements
Production downtime and equipment utilization
Audit and regulatory inspection readiness
Employee training and qualification compliance
Continuous improvement and productivity initiative
#pro123
