Production Engineer (Pharma)

Keka Technologies Private Limited; India; On-site; INR 500,000 - 900,000; Full time

Job summary

Keka Technologies Private Limited is seeking a skilled professional for shift-based operations in our pharma manufacturing facility. The role focuses on maintaining batch quality and process efficiency across granulation, blending, compression, coating, filling, filtration, and sterilization steps.

Responsibilities include conducting IPC checks, line clearance, accurate documentation, and timely deviation reporting while aligning with GMP/GDP requirements and SOPs.

Qualifications

• Problem solving
• Communication
• Production planning & execution
• Online documentation
• CAPA & SOP implementation
• Qualification & validation
• Safety and audit readiness
• Daily verification
• Training
• Stock verification
• Yield & RMC reduction
• Team leadership
• Manpower handling
• RM issue & verification

Responsibilities

• Monitor shift activities and ensure adherence to production targets.
• Perform shift handover with clear communication of ongoing activities and issues.
• Coordinate with QA, QC, Warehouse, and Engineering to ensure smooth batch execution.
• Support internal and external audits by presenting documents and demonstrating area compliance.
• Provide on‑job training to junior operators (for Sr. Officer level).
• Execute batch manufacturing operations according to BMR/BPR, SOPs, and cGMP requirements.
• Operate equipment for processes such as granulation, blending, compression, coating, filling, filtration, and sterilization (as per dosage form).
• Perform in‑process checks and document results in real time.
• Maintain and fill Batch Manufacturing Records, logbooks, and online documentation accurately.
• Report and document deviations, incidents, and OOS/OOT observations.
• Ensure strict adherence to GMP, GDP, and regulatory guidelines (USFDA, MHRA, WHO, EU‑GMP).
• Conduct and record IPC checks such as weight variation, hardness, friability, pH, volume, fill weight, and leak test.

Tools

SAP proficiency

MS Office

Job description

Responsibilities

• Monitor shift activities and ensure adherence to production targets.
• Perform shift handover with clear communication of ongoing activities and issues.
• Coordinate with QA, QC, Warehouse, and Engineering to ensure smooth batch execution.
• Support internal and external audits by presenting documents and demonstrating area compliance.
• Provide on‑job training to junior operators (for Sr. Officer level).
• Execute batch manufacturing operations according to BMR/BPR, SOPs, and cGMP requirements.
• Operate equipment for processes such as granulation, blending, compression, coating, filling, filtration, and sterilization (as per dosage form).
• Perform in‑process checks and document results in real time.
• Ensure proper line clearance before starting operations in coordination with QA.
• Maintain and fill Batch Manufacturing Records, logbooks, and online documentation accurately.
• Report and document deviations, incidents, and OOS/OOT observations.
• Ensure strict adherence to GMP, GDP, and regulatory guidelines (USFDA, MHRA, WHO, EU‑GMP).
• Update or revise SOPs as required.
• Perform routine operation, cleaning, and setup of production equipment.
• Coordinate with Engineering for preventive maintenance and breakdown troubleshooting.
• Conduct and record IPC checks such as weight variation, hardness, friability, pH, volume, fill weight, and leak test.
• Maintain product quality throughout the batch and inform supervisors immediately about any abnormalities or process deviations.

Skills

• Problem solving
• Communication
• Production planning & execution
• Online documentation
• CAPA & SOP implementation
• Qualification & validation
• Safety and audit readiness
• Daily verification
• Training
• SAP proficiency
• Stock verification
• Yield & RMC reduction
• Team leadership
• Manpower handling
• RM issue & verification
• MS Office