Research Analyst

3 days ago

Navi Mumbai, Maharashtra, India USV Full time ₹ 8,00,000 - ₹ 12,00,000 per year

Job Objective:

To enable establish QC efficient methods and processes for assigned products by performing analytical research activities while adhering to regulatory norms and established SOPs

Job Responsibilities

Analytical Method Development

  • Assist the supervisor and team leader in conducting literature review by reviewing documents such aspharmacopeia, research available in public domain, etc.
  • Conduct analytical procedures by following the trial and error methodology prescribed by Supervisor/ Team Leader to assess the workability of the proposed analytical method

Analytical Method Validation and Method Transfer as per cGMP

  • Check availability of required equipment and materials as per the method validation checklist and highlight if any discrepancies/shortfalls to enable validation exercise to be conducted as scheduled
  • Prepare method validation/ qualification protocol by planning activities and obtaining acceptable limits for tests Perform the validation exercise as per work plan (in accordance with protocol) and draft the report
  • Report any discrepancies in the results to the supervisor in a timely manner Conduct/perform the method transfer at the plant by guiding the plant QC.
  • Investigate concerns if any and help plant QC in preparing the final report
  • Ensure availability of working and reference standards by maintaining required quantity and records, and intimating CPRL when the quantity is low
  • Generate standards by doing sample analysis/characterization and preparing analytical data sheet

Documentation

  • Record the raw data contemporaneously (as it happens) in form of observations/reports and communicate to the supervisor/TL
  • Assist in preparation of Standard Analytical Procedures (SAP) document.
  • Prepare ARL related documents for regulatory submissions
  • Prepare method transfer protocol to enable transfer of methods to plant

Regulatory compliance

  • Adhere to regulatory, cGMP, SOPS and safety guidelines for all processes
  • Calibrate all instruments as scheduled
  • Ensure data integrity in all respects
  • Conduct specified tests and prepare relevant documents to aid supervisor/team leader in resolving internal/external audit queries Initiate incidence investigation

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