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.

Qualifications :-

Education:

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

Experience:

• 4 to 6 years in API/Intermediate manufacturing operations

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. Pharma – Preferred
• B.E. Chemical – Required
• B. Tech Chemical – Required

Experience:

• 2 to 5 years in API/Intermediate manufacturing operations