SENIOR EXECUTIVE
Biocon · Remote
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Employer requisition: 20337
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Collected role description
Role Summary: 1. Adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice). 2. Monitoring of laboratory environment (temperature, pressure, cleanliness, fumigation etc.) 3. Analysis should be carried out in adherence to product specifications. 4. Collection of samples for analysis and generation of analytical reference number. 5. Testing of FP, stability, method validation and testing of materials and reporting of results for Bioassay methods. 6. Review of analytical reports and review of usage logbooks, preparation of logbooks and Observation data sheets. 7. Sample processing and aliquoting in Bioassay laboratory. 8. Maintenance and subculturing of cell lines. Freezing and characterization of cells. 9. Generation and maintenance of analytical records. 10. Preparation of protocols and reports of Analytical method transfers and Analytical method validations. 11. Verification of laboratory compliance, which includes validity checking of reagents, standards, system statuses. 12. Equipment Qualification and temperature mapping. 13. Ensuring effective implementation of EHS management system in the organization. 14. Reporting and handling of QMS elements (incidents, change controls, deviations, OOT, OOS, CAPAs etc.). 15. Preparation and revision of standard operating procedures, specifications and technical documents. 16. Reserve sample storage for in process stages for different products. 17. Training on documentation, methods pertaining to Bioanalytical laboratory and re-training as per the relevant schedule. Secondary responsibility (Wherever Applicable) 1. Receipt of in-process, DS, reserve sample and stability sample and storage at QC location. 2. Calibration of analytical weighing balance and pH meter. 3. Operation and calibration of analytical instruments. Key Responsibilities: 1. Adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice). 2. Monitoring of laboratory environment (temperature, pressure, cleanliness, fumigation etc.) 3. Analysis should be carried out in adherence to product specifications. 4. Collection of samples for analysis and generation of analytical reference number. 5. Testing of FP, stability, method validation and testing of materials and reporting of results for Bioassay methods. 6. Review of analytical reports and review of usage logbooks, preparation of logbooks and Observation data sheets. 7. Sample processing and aliquoting in Bioassay laboratory. 8. Maintenance and subculturing of cell lines. Freezing and characterization of cells. 9. Generation and maintenance of analytical records. 10. Preparation of protocols and reports of Analytical method transfers and Analytical method validations. 11. Verification of laboratory compliance, which includes validity checking of reagents, standards, system statuses. 12. Equipment Qualification and temperature mapping. 13. Ensuring effective implementation of EHS management system in the organization. 14. Reporting and handling of QMS elements (incidents, change controls, deviations, OOT, OOS, CAPAs etc.). 15. Preparation and revision of standard operating procedures, specifications and technical documents. 16. Reserve sample storage for in process stages for different products. 17. Training on documentation, methods pertaining to Bioanalytical laboratory and re-training as per the relevant schedule. Secondary responsibility (Wherever Applicable) 1. Receipt of in-process, DS, reserve sample and stability sample and storage at QC location. 2. Calibration of analytical weighing balance and pH meter. 3. Operation and calibration of analytical instruments.