2 - 5 years

0 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Responsible for following the cGMP & GLP, Safety norms and adhere to companys policy.
  • To ensure compliance with Good Laboratory Practices as laid down in the Analytical Method Validation procedures.
  • Responsible for guiding a team to perform the method development and method validation of Nitrosamine impurity determination methods using LCMS and GCMS instruments.

  • Responsible for the review of Analytical documents generated during the analysis of Materials like raw materials (API and Excipients), finished products, in- process analysis by LCMS and GCMS analytical techniques.
  • Responsible for the preparation and Review of Analytical method validation, Verification and Method transfer protocols and reports.
  • Responsible for ensuring the Calibration and maintenance of the Lab instruments and Equipment’s are planned and performed on time.
  • Responsible for the Qualification of new instruments / equipment.
  • Should follow GDP for documentation.
  • Responsible for the Prompt investigation of abnormal observations of OOS, Deviation, Laboratory errors, instrument malfunctioning etc. or obvious error occurred during the analysis in coordination with Quality Assurance.

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