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