reeja.kvarghese

Lead Quality assurance for the site in compliance with ISO 13485 & ISO 9001.  Manage Manufacturing & R&D Quality Operations  Manage Audits (Regulatory – CDSCO, Notified Body and Internal)  Regulatory dossier submission for NPI & Post approval changes  Management Representative for the Site  Manage Quality Agreements  Manage Lot Release system  Support OH&S (ISO 45001) implementation  Data Analysis, Problem Troubleshooting and CAPA.  Lead Customer Complaint Review Forum & Investigations Lead QC function for Medical device and Antibodies manufacturing  QC Specification development  Batch qualification (RT-PCR, Flowcytometry, SNAP-ChIP, HPLC, Immunocytochemistry & other Immuno assays)  Manufacturing Process Optimization for New product introductions, Resource optimization, enhance efficiency, reduce costs maintaining quality standards.  Monitor functional performance KPIs and improve Quality Culture at site through initiatives.  Coach team on Problem solving, Identification of Process Improvements, Planning, Engage on Daily Tasks & Support. b) Quality Lead (Scientist II) (Jan 2019 – Nov 2020)  Ensure the QC team performance as per objectives / goals set.  Manage Mammalian cell lines for QC Requirements  Ensuring on-time testing, documentation & supply of products in compliance with the Quality systems  Review Customer complaints and drive continuous improvements.  Conduct & interpret analytical assay & lead the investigations for lot and assay failures c) Production Lead (Scientist II) (Aug 2016 – Dec 2018)  Scheduling, planning & Execution of production batches,  Review & Close batch in ERP system  Perform RCA, Investigation on lot failures and take appropriate CAPA for NCs and deviations.  Creating, reviewing & revising documents and records of the production batches, Review and closure of lot documents.  Support Internal audit and support Quality Assurance team to comply to QMS

 Design Projects and guide execution of academic & Industrial projects.  Set up cell culture facility and establish the Research facility.  Established Primary neuronal culture from Rat pups

Studied bioavailability of minerals using Cell based & cell free simulated model with selected Ayurvedic herbs.  Studied cytotoxic and antioxidant assays potential of selected Ayurvedic herbs

Compilation of Clinical Data & Reporting Establish and maintain primary fibroblast culture from human samples for culturing on Scaffold

 Maintain records for Laboratory Accreditation program.  Perform internal audit for Diagnostic center / Service Providers as per ISO 9001, National Accreditation Board for Testing and Calibration, (NABL) and College of American Pathologists (CAP).  Content Writing, on Health, Health related conditions and diagnostic measures for Health Screen (All India circulating Health Magazine).  Process and Evaluate samples all new reagents