Experience

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  Vimta labs ltd

  Jan 2012 - Feb 2014

  Ensuring the compliance to the systems & process, operations for Bio-equivalence & clinical studies as-per in house SOP and guidance such as GCP and GLP. Involved in SOP preparation, Conducting training, Internal Audit. Experienced several sponsor "study specific" audits and other regulatory audits from USFDA, MHRA, NABL & CDSCO. Involved in stability testing of finished dosage forms, Experienced in handling of sophisticated equipment and instrument like HPLC, Distek dissolution apparatus, UV spectrometer & FTIR etc.

  • Quality Auditor

    Oct 2012 - Feb 2014

  • Scientist

    Jan 2012 - Oct 2012
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  Neuland laboratories limited

  Apr 2014 - Feb 2016

  Research associate

  Implement Quality management system, Project execution and delivery at GMP accepted norms complying to highest standards of GMP regulations & laws for clinical phase and API molecules . Review of Product development report , Risk assessment, Process validation , Technology transfer documents, Analytical method validation, certification approvals, Batch manufacturing record, vendor evaluation and qualification, vendor document review, certificate of analysis, regulatory query response, Internal audit. Show less

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  Aurobindo pharma ltd

  Mar 2016 - Feb 2017

  Executive e3

  Planning, implementation and monitoring of change managaement system, risk assessment, regulatory queries resolution wrt process validation. vendor management . Tracking of CAPA and QMS metric evaluation . Continual process improvement plan implementation through compliance of QMS and measuring quality objectives, Conducting training to the subordinates on GMP and internal SOP, Audit preperation.

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  Biophore india pharmaceuticals pvt. ltd.

  Mar 2017 - Oct 2017

  Sr.executive

  Worked as Senior executive in Developmental Quality Assurance department. Implemented QMS and associated process. Reviewed technical documents related to development of finished dosage formulation , analytical method and technology transfer.

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  Biocon

  Nov 2017 - Jul 2024

  Designing manufacturing process for new product introduction into the facility through change control, CAPA, equipment qualification, process qualification and cleaning studies.Collation, analysis of both qualitative and quantitative data through technical write-ups and risk assessment by involving in product development right at proof of concept stage to drive process improvement and smoothen qualification activities for techno-commercial launch.

  • Principal Scientist

    Apr 2021 - Jul 2024

  • Senior Executive

    Nov 2017 - Mar 2021