Senior Officer, Manufacturing Process Operations

Essential Functions:

• Operate and monitor equipment used in various stages of API production such as reactors, centrifuges, dryers, millers, sifters, etc.

• Ensure cleanliness and readiness of equipment before batch charging through visual verification procedures.

• Maintain accurate records, including Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR), equipment usage logs, and deviation reports.

• Execute batch operations strictly as per SOPs and GMP guidelines.

• Monitor and record process parameters in real-time to ensure adherence to specifications and quality.

• Report and coordinate with Engineering for any equipment breakdowns during the shift.

• Coordinate with QA for issuance and submission of documents and with the warehouse for material movement.

• Handle raw materials, intermediates, and APIs, ensuring proper storage, reconciliation, and documentation.

• Follow standard procedures for sampling and in-process testing of materials and intermediates.

• Maintain cleanliness and good housekeeping in the designated manufacturing area.

• Monitor utilities in the plant (e.g., steam, vacuum, chilled water) and report abnormalities.

• Monitor and record environmental conditions like temperature, humidity, and differential pressure in clean areas (Level-I, II, III).

• Perform daily verification and calibration checks of weighing balances.

• Participate in periodic equipment cleaning and preventive maintenance.

• Ensure proper handling and disposal of hazardous materials as per environmental guidelines.

• Identify process deviations, malfunctions, or quality concerns and report them immediately.

• Support continual improvement by suggesting ideas for optimization, efficiency, and waste reduction.

• Take mandatory safety and operational training via AIMS software and participate in hands-on skill-building sessions.

• Adhere strictly to safety practices and use PPE as per company safety protocols.

• Participate in emergency response activities such as managing spills or operational incidents.

• Ensure timely inventory of plant/process-related consumables.

• Review completed manufacturing records for accuracy, completeness, and compliance with SOPs.

Additional Responsibilities:

• Support implementation of process improvement initiatives and lean manufacturing practices.

• Assist in the qualification and validation of equipment and processes as per regulatory and internal guidelines.

• Ensure readiness of the area for internal, external, and regulatory audits.

• Support investigation and documentation of deviations, change controls, and CAPAs in coordination with QA.

• Participate in cross-functional meetings to discuss production schedules, quality concerns, and improvement plans.

• Maintain discipline and GMP compliance on the shop floor and promote a culture of accountability.

• Train and mentor junior staff/operators on standard procedures and safe working practices.

• Assist in preparation and review of SOPs related to manufacturing activities.

• Support periodic review of equipment performance and suggest improvements for efficiency.

• Ensure adherence to environmental and safety norms in chemical handling and waste disposal.

• Actively participate in safety drills, risk assessments (HIRA), and incident investigations.

• Coordinate with stores for timely availability of raw materials, consumables, and packing materials.

• Report daily production updates to the shift in-charge or supervisor as required.

Skills:

• API Manufacturing Operations – Intermediate to Advanced

• Batch Documentation (BMR/BCR/BPR) – Intermediate

• GMP Compliance and Data Integrity – Intermediate

• Process Monitoring and Troubleshooting – Intermediate

• SOP Adherence and Equipment Operation – Intermediate

• Safety and Emergency Response – Intermediate

• Material Handling & Inventory Control – Basic to Intermediate

• Utilities & Cleanroom Parameter Monitoring – Basic

• Team Coordination and Communication – Intermediate.

Qualifications :-

Education:

• Master Degree, M. Sc – Organic Chemistry - Preferred
• Bachelor Degree, B. Sc. – Preferred
• B.E. Chemical – Required
• B. Tech Chemical – Required

Experience:

• 2 to 5 years in API/Intermediate manufacturing operations