Executive, Manufacturing Process Operations

Senior Officer – Manufacturing Process Operations is responsible for executing processes in the API manufacturing plant, ensuring product quality, regulatory compliance. This role includes operating key equipment, maintaining GMP documentation. The position requires a strong understanding of chemical process operations, safety standards, and documentation practices.

Essential Functions:

• having knowledge on operation of manufacturing equipment

• Should Have Knowledge of hybrid technologies / Molecular Hiving preferred.

• Exposure to scale-up processes will be an added advantage.

• 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.
• Report and coordinate with Engineering for any equipment breakdowns during the shift.
• 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).
• Ensure proper handling and disposal of hazardous materials as per environmental guidelines.
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Additional Responsibilities:

• 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.
• Should investigate and documentation of deviations, change controls, and CAPAs in coordination with QA.
• Maintain discipline and GMP compliance on the shop floor and promote a culture of accountability.
• 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.

Qualifications: -Education:

• Master’s degree, M. Sc – Organic Chemistry – Preferred

• Master’s degree, M. Pharmacy- Preferred

• BE/ Btech Chemical engineering

Experience:

• 05 to 07 years in Peptide/ API/Intermediate manufacturing operations

Skills:

• Preparation of BMR and technical documents (IQ, OQ, PQ, etc.).

• API Manufacturing Operations – Intermediate to Advanced

• Process Monitoring and Troubleshooting – Intermediate

• Material Handling & Inventory Control – Basic to Intermediate