
Research Associate I, R&D - ADL
- Ahmedabad, Gujarat
- Permanent
- Full-time
- To complete the planned work (Method validation/Submission Studies/Regulatory query) in stipulated time frame given by sub-department manager.
- To perform all the 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.
- To operate the different instruments like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter etc. as per approved standard operating procedures.
- To calibrate the Instruments as and when required (Daily/as per schedule) like HPLC, GC, Balance, Auto titrator, Karl Fisher Titrator, pH meter etc. as per approved standard operating procedures.
- To use live reference standards, working standards and Impurity Standards for analysis and maintain their records.
- To verify the shelf life of chemicals and reagents before performing analysis of material or product.
- To follow good documentation and ALCOA++ practices.
- To follow the good Laboratory practices in the Department.
- To follow the instruction and procedure as mentioned in the approved protocol.
- To keep track of routine requirements. Inform and ensure timely procurements of the same to respective person or Department.
- To Report and investigate any failure / abnormal observation / deviation / Non-Compliance to sub-department manager and seeking for the solutions.
- To communicate project related issues to sub-department manager and follow the action plans.
- To check the trend of results before reporting the results.
- To keep the status of daily work and report to sub-department manager on daily basis.
- To prepare standard operating procedures (SOPs) and standard formats for Documentation.
- To verify the instruments after maintenance of the Instruments.
- To check preventive maintenance, Breakdown Maintenance and perform risk assessment. To report preventive maintenance and Breakdown Maintenance to sub-department manager.
- To represent subject matter expertise in the areas of analysis internally and externally as needed.
- To make Analytical problem-solving efforts to meet urgent business needs.
- To focus on innovation, process improvement, and/or operational excellence.
- To execute and manage projects/programs utilize established methods, techniques, or approaches.
- To Implement new or improved techniques and procedures around specific tasks; write and implement SOP's.
- To complete the training as per the quality matrix targets.
- To Maintain knowledge of relevant regulatory requirements related to R&D to ensure compliance in all research, data collection and reporting activities.
- In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance.