Swetha N

Accomplished Lead CSV, IT-Compliance & Corporate Quality Assurance professional with over 15 years of experience in pharmaceutical quality systems at Biocon Ltd. Expert in GxP compliance, 21 CFR Part 11, ISO standards, and computerized system validation with a proven track record of driving regulatory excellence and organizational growth. Self-directed and Quality focused IT, Computer System Validation (CSV) and compliance specialist with 15+ years of Functional and IT experience across Pharmaceutical & IT services.

Skilled in implementing leading compliance strategies and delivering validated, audit ready enterprise systems aligned with global regulatory norms. Recognized for ensuring robust compliance frameworks, driving operational excellence and enabling seamless regulatory inspections through technical expertise and strategic leadership.

Associate Manager – Corporate Quality Assurance at Biocon Ltd. (2025-07 – Present)

Deputy Manager – Corporate Quality Assurance at Biocon Ltd. (2020-07 – 2025-06)

Assistant Manager – Corporate Quality Assurance at Biocon Ltd. (2018-07 – 2020-06)

Assistant Manager – Quality Control at Biocon Ltd. (2016-07 – 2018-06)

Senior Executive – Quality Control at Biocon Ltd. (2014-07 – 2016-06)

Executive – Quality Control at Biocon Ltd. (2010-09 – 2014-06)

Intern, Quality Control department at Biocon Ltd. (2010-06 – 2010-09)

Gained hands on exposure to Pharmaceutical quality controls practices including analytical testing, documentation & compliance with industry standards.

M.Sc. in Analytical Chemistry – St. Aloysius College, Mangalore (2008 – 2010)

B.Sc. in Chemistry – Bhandarkar's Arts & Science College, Kundapura (2005 – 2008)

DCA in Diploma in Computer Application – Manipal University