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Senior Officer, Manufacturing Process Operations
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Essential Functions:
JOB DESCRIPTION
Education:
Qualifications :-
Experience:
JOB DESCRIPTION
- 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.
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Review completed manufacturing records for accuracy, completeness, and compliance with SOPs.
- 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.
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Report daily production updates to the shift in-charge or supervisor as required.
Education:
- Master Degree, M. Sc – Organic Chemistry - Preferred
- Bachelor Degree, B. Pharma – Preferred
- B.E. Chemical – Required
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B. Tech Chemical – Required
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4 to 6 years in API/Intermediate manufacturing operations
- 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
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Team Coordination and Communication – Intermediate.
Qualifications :-
Experience:
- 2 to 5 years in API/Intermediate manufacturing operations
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