Senior Executive

Position Title:

Key Responsibilities:

• Ensure adherence to

  GLP and laboratory safety procedures

  at all times.
• Perform

  analytical testing

  of raw materials, packing materials, intermediates, APIs, finished products, and stability samples as per current specifications and methods of analysis.
• Carry out

  HPLC analyses

  and online documentation for in-process, intermediates, finished products, returned goods, hold-time studies, stability samples, and working standard analysis as per approved SOPs.
• Maintain

  CFR 21 Part-11 compliance

  and ensure proper documentation and data integrity during all analyses.
• Record analytical results in worksheets, LIMS, and other designated records accurately and promptly.
  
• Ensure correct usage of specifications and methods of analysis for respective product/material codes.
  
• Follow instructions of Shift/Section In-charge for daily analysis and planning.
  
• Report and initiate investigations for

  QI/NQI/OOS/OOT/Deviation

  or any discrepancies observed during analysis.
• Perform

  calibration of laboratory instruments

  as per defined schedule and maintain proper calibration records and status tags.
• Maintain

  instrument logbooks, column performance logs, and instrument history records

  .
• Prepare and maintain

  reference standards, working standards, and impurity standards usage records

  .
• Participate in

  analytical method transfer (AMT)

  and joint analysis with Analytical Research (AR) laboratory personnel.
• Prepare

  stability protocols, stability reports

  , and conduct analysis of stability samples as per schedule.
• Monitor and record

  temperature and humidity

  of laboratory areas, refrigerators, and stability chambers daily.
• Conduct

  holding time studies

  for intermediates and prepare reports.
• Ensure good chromatographic practices and proper

  integration, review, and storage of chromatographic data

  (online/offline).
• Ensure safe handling of laboratory chemicals and solvents, and prevent spillage or wastage.
  
• Prepare mobile phases and analytical solutions efficiently to minimize reagent consumption.
  
• Coordinate with the

  stores department

  for timely availability of raw materials and consumables required for urgent analyses.
• Continuously

  upgrade technical knowledge

  through training and ensure adherence to cGMP and quality systems.