Responsible for analytical method validation (AMV), Analytical method transfers (AMT), Analytical method equivalencies (AME) for injectable projects with tests such as Assay, Related substances, Content estimation, Molecular weight determination, CCIT, PSD, Cleaning validation etc.
Responsible for Analytical method development, feasibility studies for injectable products tests such as Assay, related substances, preservative content, molecular weight, cleaning method and reverse engineering for product elucidation as and when required.
Preparation of Test data sheets, Protocols and Reports for AMV, AMT and AME studies.
Perform query related activity for injectable projects.
Review of pre-validation data prior to start of Analytical method validations.
Preparation of analytical method development reports, documentation in LNB, TDS/LIMS, as applicable as per GLP/GMP compliance.
Responsible for interpretation of analytical data and communicating the same to concern groups & individuals.
Responsible for operation & calibration of various Analytical instruments.
Ensure applicable SOP's training during routine working.
Responsible for day-to-day analytical laboratories activities.
Responsible for maintaining work area as per safety guideline.
Responsible for verifying availability of pre-requisites of validation with respect to individual projects.
Responsible for completion of calibrations and monthly flushing of systems within stipulated timelines.
Ensure compliance to all cGMP, GLP or any other regulatory requirements, including EH&S requirements.
Ensure integrity of data generated during routine working and to follow ALCOA principles.
Work ExperienceHave experience in Analytical Method validations over a period of 9 years. Work experience details are as follows,November 2022 - March-2025-Assistant Manager- Analytical Method Validation Department, Cadila Pharmaceutical Limited, Ahmedabad, India. May 2017 - October 2022-Analytical Scientist-II - Analytical Method Validation Department, Aurobindo Research Center-I, Hyderabad, India. May 2015 - April 2017-Executive - Micro Labs, Technology transfer, Goa, India.EducationMasters in PharmacyCompetencies