Sunil K S
Quality Assurance & QC Professional | IVD & Pharmaceutical | ISO 13485 & cGMP Specialist
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About
Quality-focused Biochemistry postgraduate with 7+ years of experience in Quality Control and Quality Assurance across IVD and pharmaceutical industries. Expertise in ISO 13485, ISO 9001, cGMP, and GLP compliance, with strong capabilities in QMS management, deviation handling, CAPA, and regulatory audits. Proven track record in ensuring product quality, supporting manufacturing excellence, and driving continuous improvement initiatives.
Experience
Assistant QC/QA at MEDpro Medical BV (2025-12 – Present)
- Perform incoming goods inspection as per quality plans
- Coordinate purchase orders, shipments, and supplier follow-ups
- Ensure QA compliance for contract-manufactured products
- Maintain and update QMS documentation
- Support supplier audits and regulatory compliance
Scientist I at Thermo Fisher Scientific (2021-11 – 2025-12)
- Analyzed IVD & RUO products in compliance with ISO 13485 & ISO 9001
- Prepared and reviewed SOPs, work instructions, and quality documents
- Conducted raw material & finished goods trending analysis
- Executed line clearance and batch record review
- Managed deviations, CAPA, and change control in TrackWise
- Conducted GEMBA walks for quality and safety improvements
- Delivered internal training on quality systems
Quality Control Officer – I at Medreich Pharmaceutical Company (2018-10 – 2021-11)
- Performed in-process and finished product analysis
- Prepared packaging specifications and Certificates of Analysis (CoA)
- Maintained GLP-compliant documentation
- Supported internal and external audits
- Ensured compliance with cGMP and SOPs
Education
M.Sc. in Biochemistry – Ramaiah College (2018)
B.Sc. – Vijaya College (2016)
