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Job highlights

Work/Life Balance

Time management

Flexibility

Problem Solving

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.

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