Akash Dessai

Experience

• 

  ICMR - National Institute for Research in Reproductive and Child Health (NIRRCH)

  Jan 2014 - Jun 2014

  Research Trainee

  ● Worked on the project “To study the differential expression of HMGB1 and RAGE in blood of Diabetic Non-Human Primates (Macaca radiata)”; ● Performed Biochemistry techniques like Western Blotting, Flow Cytometry, qPCR, ELISA, etc.

• 

  Lilac Insights

  Jun 2015 - Feb 2016

  Scientific Officer

  ● Performed Cytogenetic techniques like Cell Culture, Chromosome Preparation by GTG banding, Chromosome Analysis (Karyotyping) using Zeiss Metasystem Software, FISH analysis on Human Chromosomes; ● Prepared test reports and provided the technical support to customers.

• 

  Law firm

  Aug 2016 - Nov 2022

  Office Manager

  ● Fulfilled general administrative duties required for proper functioning of the firm having 5 lawyers and 4 employees ● Managed operations by maintaining office systems and supervising staff; ● Handled Government Portal for various legal appeals; ● A liaison between Clients and Lawyers by scheduling meetings and keeping real time track of legal work; ● Reviewed official documents prepared by staff ● Cross Cultural Experience

• 

  Molbio Diagnostics

  Dec 2022 - now

  ● Complying and Maintaining Quality Standards of the Company; ● Involved in preparation and compilation of country/ organization specific Dossiers (CDSCO, IVDR, WHO, ERPD - The Global Fund, ROW countries, US FDA, Brazil, etc.) ● Submissions of Technical Documentation to the regulatory bodies ● Verification of Stability, Analytical Performance, Clinical studies, etc; ● Performing GAP Analysis and Implementation of new Standards in the system; ● Part of a Post-Marketing Surveillance Committee and maintaining a close relationship with Sales Team for Technical Support, Product Management and Artwork Compliance ● Faced multiple external audits as a core team member including ISO 13485:2016, MDSAP certification by TÜV SÜD, WHO prequalification, CDSCO, etc. ● Part of a team for Internal Quality Audits (IQA) ● Vigilance activities ● Preparation and providing training of SOPs; ● PowerPoint presentations on Products/ Organization ● MOM preparation ● Root-cause Analysis and CAPA ● Sound knowledge of ISO 14971:2019 (Risk Management), MDR, IVDR Regulation 2017/746, IMDRF, CLSI, WHO (TGS & TSS) guidelines, etc. Show less ● Complying and Maintaining Quality Standards of the Company; ● Preparation of Country/ Organization specific (CDSCO, IVDR, WHO, ERPD, US FDA, The Global Fund, ROW countries, etc.) Technical Dossiers (DMF); ● Preparation and providing training of SOP’s and Formats; ● Verification of Stability Studies, Analytical Performance studies and Artwork/ IFU; ● Performing GAP Analysis; ● Faced EN ISO 13485:2016 certification audit and team member for MDSAP implementation by TÜV SÜD ● Part of Team for Internal Quality Audits (IQA) ● Knowledge of EN ISO 14971:2019 (IVD Risk Management) ● Cross Cultural Experience Show less

  • Senior Officer (Quality Assurance - Regulatory Affairs)

    Apr 2024 - now

  • Quality Assurance Officer (Regulatory Affairs)

    Dec 2022 - Apr 2024