Production Executive

Executive Spray Dryer Operations / Shift In-Charge

Department: Production
Industry: API / Life Sciences / Bulk Drugs
Location: Padra, Vadodara
Designation: Executive – Production
Experience: 3–6 Years (relevant experience in API manufacturing and spray dryer operations preferred)
Qualification: B.Sc. / M.Sc. Chemistry, B.Pharm, or Diploma / B.E. in Chemical Engineering

Job Summary

Responsible for operating and monitoring spray dryer equipment in an API / Life Sciences manufacturing plant, ensuring safe and efficient operations, adherence to approved manufacturing procedures, and compliance with cGMP, EHS, and quality requirements. The role also involves handling shift in-charge responsibilities, including manpower allocation, production coordination, documentation, equipment monitoring, and shift handover.

Key Responsibilities

1. Spray Dryer Operations

• Operate and monitor spray dryer systems used in API / intermediate manufacturing as per approved SOPs and Batch Manufacturing Records (BMRs).
• Monitor and control critical process parameters, including inlet and outlet temperatures, feed rate, atomization pressure, airflow, and drying conditions, as applicable to the process.
• Ensure proper equipment setup, pre-startup checks, line clearance, and readiness before commencing operations.
• Monitor product drying, yield, moisture content, and other specified process parameters as per approved procedures.
• Coordinate equipment cleaning, product changeover, and preventive maintenance activities to ensure smooth operations.
• Identify process deviations, equipment abnormalities, and operational issues, and escalate them to the reporting manager.

2. Shift In-Charge Activities

• Manage day-to-day production activities during the assigned shift and ensure adherence to the production plan.
• Allocate manpower and assign responsibilities to operators and technicians based on shift requirements.
• Monitor production progress, equipment utilization, process performance, and adherence to the approved schedule.
• Ensure effective coordination with QA, QC, Engineering, EHS, and other relevant departments for smooth production operations.
• Conduct shift briefings and ensure proper handover of production status, equipment conditions, pending activities, and process-related concerns.
• Monitor operator performance, discipline, housekeeping, and compliance with established safety procedures.

3. Documentation and cGMP Compliance

• Ensure accurate, complete, and timely entries in BMRs, equipment logbooks, cleaning records, and other applicable production documents.
• Follow cGMP, GDP, data integrity, and site quality requirements during all manufacturing activities.
• Ensure compliance with approved SOPs, batch instructions, line clearance requirements, and material traceability procedures.
• Report deviations, incidents, process abnormalities, and non-conformances promptly to the concerned authority.
• Support investigations, CAPA implementation, and audit-related activities as assigned.

4. Safety and Equipment Management

• Ensure compliance with EHS requirements, PPE usage, and safe operating practices during spray dryer operations.
• Follow applicable precautions for handling solvents, process chemicals, combustible dust, and other process-specific hazards.
• Ensure equipment cleaning, area cleanliness, and safe handling of materials in accordance with approved procedures.
• Coordinate with the Engineering and Maintenance teams for breakdown resolution and equipment performance improvement.
• Ensure proper waste handling and compliance with site environmental and safety standards.

Required Skills and Competencies

• Hands-on experience in spray dryer operations in an API, bulk drug, or life sciences manufacturing facility.
• Knowledge of API / intermediate manufacturing processes and production documentation.
• Ability to independently manage shift operations and supervise production personnel.
• Understanding of cGMP, GDP, SOPs, BMRs, EHS, and data integrity requirements.
• Good troubleshooting, problem-solving, and coordination skills.
• Ability to manage production priorities, maintain process discipline, and ensure timely shift handovers.

Preferred Candidate Profile

Candidates with relevant experience in spray drying operations in an API / Life Sciences manufacturing plant, along with the ability to independently handle shift in-charge activities, production manpower, equipment monitoring, and cGMP-compliant documentation, will be preferred.

Note: Experience requirements and qualification criteria may be adjusted based on the plant's specific process and operational requirements.