Key Responsibilities:
- Complete the planned work (Method development / Method validation/routine stability sample analysis) within the stipulated timeframe provided by the sub-department manager.
- Perform all testing and data recording of API samples, Development Product samples, Validation Samples, Stability samples, Bulk hold samples, RLD samples, PDR samples, etc., according to draft/approved Method of analysis or current Pharmacopoeia.
- Operate different instruments like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter, etc., as per approved standard operating procedures.
- Calibrate the Instruments (Daily/as per schedule) like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter, etc., as per approved standard operating procedures.
- Make entries in the respective logbook, when starting the analysis and upon completion of the analysis.
- Use live reference standards, working standards, and Impurity Standards for analysis and maintain their records.
- Verify the shelf life of chemicals and reagents before performing analysis of material or product.
- Follow good documentation practices and Laboratory Practices in the Department.
- Adhere to instructions and procedures as mentioned in the approved protocol.
- Keep track of routine requirements, inform, and ensure timely procurement to the respective person or Department.
- Report and investigate any failure, abnormal observation, deviation, or Non-Compliance to the sub-department manager and seek solutions.
- Communicate project-related issues to the sub-department manager and follow action plans.
- Check the trend of results before reporting the results.
- Maintain the status of daily work and report to the sub-department manager on a daily basis.
- Prepare standard operating procedures (SOPs) and standard formats for Documentation.
- Verify instruments after maintenance.
- Check preventive maintenance, Breakdown Maintenance, and perform risk assessments. Report preventive maintenance and Breakdown Maintenance to the sub-department manager.
- Represent subject matter expertise in analysis internally and externally as needed.
- Make analytical problem-solving efforts to meet urgent business needs.
- Focus on innovation, process improvement, and operational excellence.
- Execute and manage projects/programs utilizing established methods, techniques, or approaches.
- Implement new or improved techniques and procedures around specific tasks; write and implement SOPs.
- Maintain knowledge of relevant regulatory requirements related to R&D to ensure compliance in all research, data collection, and reporting activities.
