Senior Quality Assurance Associate
1 month ago
Job Summary:
We are seeking a highly skilled Senior Quality Assurance Associate to join our team at Syngene. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.
Key Responsibilities:
- Adhere to Good Manufacturing Practices (GMP) standards and ensure compliance with regulatory requirements.
- Monitor and control production operations to ensure that products meet the required quality standards.
- Perform calibration checks on instruments and equipment to ensure accuracy and reliability.
- Verify equipment readiness for manufacturing activities and ensure that all necessary materials are available.
- Ensure the cleanliness of raw materials and packaging materials before bringing them into the plant.
- Receive and check raw and packing materials against Batch Manufacturing Records (BMR) and issue slips with appropriate labels.
- Maintain a clean and organized working area and ensure that all necessary consumables are available.
- Monitor and control production operations as per BMR and perform batch charging, filtration, work up, and drying activities.
- Operate the Distributed Control System (DCS) as per process requirements and update operations in the BMR.
- Conduct online documentation during batch execution and ensure that all necessary documents and annexures are filled and maintained.
- Update and maintain equipment logbooks and daily checklists.
- Report any deviations or variations to the supervisor for further action.
- Implement corrective actions in coordination with relevant team members.
- Cross-check and hand over mother liquor, aqueous layer, spent solvent, and spent solid for disposal upon concurrence from shift in-charge.
- Submit samples to Quality Control (QC) and prepare for the next step.
- Shift Coordination: Take charge from the previous shift by checking reaction conditions with the BMR, equipment cleanliness checklist (ECC), and availability of raw materials and solvents. Complete operations within BMR-specified timings. Provide shift updates to superiors on project and plant status.
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