BI

Executive / Senior Executive - Analytical Development

Biological E
Hyderabad ₹3-8 LPA Posted 20 May 2025
FULL TIME
Calibration
Qms
Regulatory Compliance
Sops
Method Validation

Job Description

  • To perform analysis ensuring compliance with respect to GLP, GDP, cGMP and regulatory requirements.
  • Perform the analytical test / methods as assigned by team lead / reporting manager.
  • Preparation of Method Validation/Verification/Transfer protocols, reports and submit for review.
  • Perform Analytical Method validations / verifications/Transfers as assigned by team lead / reporting manager.
  • Perform calibration of different equipments as assigned by team lead / reporting manager.
  • Follow the Standard Operating Procedures while operating the different instruments/equipments.
  • Report any problems with tests, equipment or results to the immediate supervisor.
  • Perform laboratory duties by receiving samples from other departments.
  • Recording of analytical results in the appropriate Lab note books.
  • Maintenance of chemicals/equipments as per the standard operating procedures.
  • Procurement of laboratory chemicals/reagents/standards/columns.
  • Ensure calibration of equipment before use and inform the supervisor as required.
  • Keep lab work areas clean and organized.
  • Initiate QMS elements like Change controls, Deviations, LIR and CAPA's pertaining to validation lab.
  • Execution of experiments to address regulatory queries/deficiencies for dossier filings.
  • Responsible for preparation of standard operating procedures.
  • To participate in internal, customer and regulatory audits as and when required.
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