ADL Pellets Executive Ass Manager

2 weeks ago


Vadodara, Gujarat, India Job Excel Full time
  • DefineObjectives andRequirements :Clearly outline the purpose of the analytical methods. Determinewhat parameters need to be measured such as assay potencyimpurities and dissolution profile. Understand regulatoryrequirements and industrystandards.
  • LiteratureReview :Conduct a thorough literature review to understand existing methodsand technologies relevant to pellet formulation analysis. Identifyany gaps or areas forimprovement.
  • MethodDevelopment :
    • Selectappropriate analytical techniques based on the properties of thepellet formulation. Common techniques include HPLC (HighPerformanceLiquid Chromatography) GC (Gas Chromatography) UVVis spectroscopyetc.
    • Optimizeconditions such as mobile phase composition column type temperatureetc. for eachmethod.
    • Developmethods for impurity detection and quantification ensuringsensitivity andselectivity.
    • Establishdissolution methods to assess the release profile of activeingredients from thepellets.
  • MethodValidation :
    • Conductmethod validation according to regulatory guidelines (e.g. ICHFDA).
    • Validateparameters such as specificity accuracy precision linearityrobustness and limit of detection/quantitation for eachmethod.
    • Performforced degradation studies to assess methodrobustness.
    • Ensurevalidation protocols are welldocumented andreproducible.
  • DocumentationandReporting :
    • Documentall method development and validation activities in detailincluding protocols results and any deviationsencountered.
    • Preparecomprehensive validation reports summarizing the methodologyresults andconclusions.
    • Ensuredocumentation complies with regulatory standards and internalqualityprocedures.
Requirements Provenexpertise in HPLC GC dissolution testing and other analyticaltechniques commonly used in pharmaanalysis.
Proven expertise inHPLC, GC, dissolution testing and other analytical techniquescommonly used in pharma analysis.

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