Key Accountabilities and Responsibilities:·       Analytical Method Development of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray. ·       Analytical Method Validation of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray. ·       Analytical Method Transfer of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray.

JOB SPECIFICATIONAnalytical method development and validation for pharmaceutical dosage forms.Literature search related to the drug substance, create analytical profiles.Execution of analytical method transfer for pharmaceutical dosage forms.Analysis of routine samples (product development batches, stability study samples, raw materials etc.).Operation and Calibration of analytical instruments/equipment’s.Qualification of working standards.Data Review and Release (as assigned).Documentation of analytical activities as per Good documentation practices.Work in laboratory as per Good laboratory practices.To use PPEs and follow safe practices in lab.Preparation of SOPs, STPs, Specifications, COAs and stability reportsPreparation of RM Specification and STPsTrouble shooting of analytical issues/problems/queries.Review of Analytical development & stability data.Analytical Activities related to Quality Control Department.Any other task assigned by management.

Competencies Required:

Good Knowledge about Analytical Method development, Validation and method transferKnowledge about the Regulatory requirement and Quality requirementMust be able to perform the analysis as per the Good Laboratory Practices

Functional Skills/ Know-how:Hands on experience on HPLC, GC, UV spectrophotometer, IR spectroscopy, Dissolution Test Apparatus, Disintegration Test Apparatus, Viscometer, Differential Scanning Calorimetry (DSC), Malvern Particle sizer.