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Experiences

Current Experience

  • Quality Control Supervisor


    Since February 2015

Past Experience

  • Manager, QC

    January 2010 --- January 2012
    key functions - management of all aspects of quality Testing Laboratory in a GMP grade Cell processing & banking facility - team lead for a group of 8-10 budding life science professionals - qualified Trainer for Quality Control functions - Internal Auditor for cross-finctional audits - represent quality unit for regulatory audits - FDA, ISO 13485, GMP, glp - Validation & Qualification studies for Analytical methods, equipements, processes for existing & new products - Testing support for ongoing in-house Research initiatives

  • Senior Quality Control Engineer

    January 2009 --- January 2010
    monitor the Testing, Data Analysis, interpretation & reporting & trouble-shooting for - Cell potency Assays for inprocess & final products - tests for purity, stability & safety for final products - Cell proliferation assay to check for efficacy - screening for transmissible diseases - environmental monitoring of clean classified areas

  • Scientific Officer

    January 2008 --- January 2009

  • Research Assistant

    January 2007 --- January 2008
    undertook study for evaluation of differential Phenotype in hematopoietic Stem Cells obtained from normal individuals & patients suffering from various hematological disorders, under the guidance of dr. potdar. also included assessment of epigenetic regulation of tumor suppresor genes.

  • Clinical Research Associate (CRA)

    January 2005 --- January 2006
    being a part of srl, as a Clinical reference Laboratory, i was involved in monitoring assigned Clinical studies, set-up of study centres including staff Training, design & preparation of study manual, Investigator manual & other related documents as per requirement. also dealt with Customer Service for Investigator- sponsor queries & collation & archival of study Documentation

Knowledge

LinkedIn Assessment :
Microbiologymolecular biologyFlow CytometryPCRELISAGLPGMPQuality SystemsSOPValidationQCISO 13485LifesciencesSOPQuality SystemCell CultureFDAQuality AssuranceStem CellsImmunologyMedical DevicesChange ControlClinical trialsTechnology transferBiotechnologyRegulatory affairsCAPASDS-PAGELife SciencesQuality Control

Education

  • Advanced Diploma in Patent & Regulatory Management from Institute for Pharmaceutical Education & Research in 2011
  • Advanced Diploma in Quality Assurance Management from Institute for Pharmaceutical Education & Research in 2010
  • M.Sc. in Microbiology from University of Mumbai in 2005
  • B. Sc. in Microbiology from University of Mumbai in 2003

Languages

BrightOwl Assessment:
Self Assessment:
English
Native
French
Elementary Proficiency

Area / Region

Nyon, Switzerland

Others

Driving License
  • No

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