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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