Description

Production Officer – API Manufacturing

Department: Production
Function: API Manufacturing
Designation: Production Officer
Reports To: Production Executive / Shift In-Charge / Production Manager
Location: API Manufacturing Plant

1. Job Purpose

To execute and supervise day-to-day API manufacturing operations safely and efficiently, ensuring achievement of production targets while maintaining GMP, quality, EHS, productivity and documentation standards.

2. Key Responsibilities

A. Production Operations

- Execute daily production activities as per the approved production plan and batch manufacturing instructions.
- Monitor and supervise manufacturing activities across assigned production areas.
- Carry out operations such as:
-

- Raw material charging
- Reactor operations
- Reaction monitoring
- Filtration
- Centrifugation
- Washing
- Drying
- Milling / Micronization
- Packing and material transfer

- Ensure manufacturing activities are performed strictly as per approved SOPs and Batch Manufacturing Records.
- Monitor critical process parameters and immediately report deviations or abnormalities.
- Ensure timely completion of batches as per defined cycle time.

B. Shift Management

- Take proper handover from the previous shift and communicate critical activities to the next shift.
- Allocate work to operators / union workers based on production requirements and competency.
- Monitor manpower deployment and utilization during the shift.
- Coordinate with Maintenance, QA, QC, Warehouse, EHS and Engineering for uninterrupted production.
- Escalate critical operational issues to the Shift In-Charge / Production Manager.

C. GMP & Documentation

- Ensure strict compliance with GMP, SOPs, GDP and data-integrity requirements.
- Complete Batch Manufacturing Records, logbooks,



checklists and other production documentation accurately and in real time.
- Ensure proper line clearance and equipment status before starting manufacturing activities.
- Report deviations, incidents and process abnormalities immediately.
- Support investigations, CAPA, change controls and other quality-system activities.

D. Quality Control & Process Compliance

- Monitor critical process parameters during manufacturing.
- Coordinate with QC for sampling and testing requirements.
- Ensure only approved materials are used in manufacturing.
- Maintain proper identification and status labelling of materials and equipment.
- Prevent cross-contamination and mix-ups through strict adherence to procedures.

E. Equipment & Process Monitoring

- Ensure proper operation of reactors, centrifuges, filters, dryers, pumps, vacuum systems, mills and other production equipment.
- Conduct routine checks of equipment condition and report abnormalities.
- Coordinate with Maintenance for breakdowns and equipment-related issues.
- Ensure equipment cleaning and changeover activities are completed as per SOP.

F. Safety & EHS

- Ensure protected execution of all manufacturing activities.
- Follow PPE, work permit, LOTO and chemical-handling requirements.
- Ensure safe handling of solvents, chemicals, compressed gases and hazardous materials.
- Participate in toolbox talks, safety training, emergency drills and near-miss reporting.
- Immediately report unsafe conditions, spills, incidents and near misses.




- Ensure workers follow all applicable safety procedures.

G. Housekeeping & 5S

- Maintain cleanliness and housekeeping of production areas.
- Ensure proper disposal and segregation of process waste.
- Drive 5S practices within the assigned area.
- Ensure equipment and surrounding areas remain clean and organized.

H. Productivity & Continuous Improvement

- Support achievement of production targets and planned batch cycle times.
- Identify opportunities to reduce process losses, downtime and material wastage.
- Participate in Kaizen, productivity improvement and manufacturing excellence initiatives.
- Support improvement in yield, equipment utilization and manpower productivity.
- Ensure minimum avoidable production losses.

3. Key Performance Indicators

- Production plan achievement %
- Batch cycle-time adherence
- Yield %
- OEE / equipment utilization
- Production downtime
- Batch right-first-time %
- Documentation compliance
- Deviation / incident rate
- GMP compliance
- Manpower productivity
- Material and process loss
- Housekeeping / 5S compliance
- Safety performance

4. Qualification & Experience

Qualification:

- B.E./B.Tech in Chemical Engineering / relevant engineering discipline.
- B.Sc./M.Sc. in Chemistry or relevant qualification may be considered based on plant requirements.

Experience:

- 2–6 years of experience in API / pharmaceutical / chemical manufacturing.
- Hands-on experience in batch manufacturing and process operations preferred.
- GMP-regulated manufacturing experience preferred.

5. Required Skills

- Good understanding of API manufacturing processes.
- Knowledge of reactors, centrifuges, filtration and drying operations.
- Understanding of GMP and production documentation.
- Strong problem-solving and troubleshooting ability.

📌 Officer (India)
🏢 Cadila Pharmaceuticals
📍 India