Job Description
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
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
