Swapna Simon
Quality Assurance Officer @Diagnostics Biochem Canada Dbc
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WORK HISTORY
Quality Assurance Officer @Diagnostics Biochem Canada Dbc
London, ON, CA
Act as a Quality Assurance representative in in-vitro diagnostics medical devices regulatory compliance life cycle management at DBC. Ensures policies and procedures related to the company\'s quality assurance and compliance requirements are followed in accordance with ISO 13485, Canadian Medical Devices Regulations (SOR/98-282), FDA -Code of Federal Regulations (CFR), EU IVDR (2017/746) etc.Ensures Non-conformances and deviations are addressed by proper quality investigations, CAPA and Internal & External auditingEnsures quality documentation of calibration and instrument qualifications (IQ,OQ,PQ)
EDUCATION
Academy of Applied Pharmaceutical Sciences
Post Graduate Diploma, Professional Regulatory Affairs
Bharathiar University
Doctor of Philosophy - PhD, Biological Science/ Biotechnology
Mahatma Gandhi University
Bachelor's degree, Botany/Chemistry
Academy of Applied Pharmaceutical Sciences
Post Graduate diploma QA/QC, Pharmaceutical Quality Assurance and Quality Control
Bharathiar University
Master's Degree, Applied Biotechnology
ABOUT SWAPNA SIMON
A detail-oriented Quality & Regulatory Compliance Specialist with proficiency in Canadian GXP, ISO 13485, Canadian Medical Devices Regulations (SOR /98-282), US FDA 21CFR regulations, European IVDR -in Pharmaceutical and Medical Devices industries in Product quality compliance management, Auditing (Internal, HC External, MDSAP), ICH, QSP, SOPs and work procedure writing, FDA responses, Deviation reports, Corrective and Preventive actions, validations, GMP checks, Training and country specific Regulatory compliance activities with business acumen, Post Market Surveilance, R&D/QC laboratory project management experience in the Pharmaceutical, Medical Device, and Agro/chemical regulated global market.Data Integrity management skills with Computer proficiency in MS Office, Outlook, and software such as R, SPSS, Trackwise, SAP, TruVault, Phoenix, Empower, Millennium 32, ChemStation, Cary WinUV, etc, and other technical software, LIMS etcCore Strengths: Execution of Quality Compliance, Regulatory activities with Project/Data/Documentation Management
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