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.
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
