Swetha N

Accomplished Lead Computer System Validation (CSV), IT-Compliance & Corporate Quality Assurance professional with over 15 years of experience in pharmaceutical quality systems at Biocon Ltd. Proven expert in GxP compliance, FDA 21 CFR Part 11, EU Annex 11, ISO standards and Data integrity frameworks. Track records of driving regulatory excellence, managing end-to-end software validation lifecycles, and leading cross functional teams to deliver audit ready enterprise infrastructure.

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

• Validation Strategy: Defined end-to-end validation strategies for corporate GxP systems, serving as core regulatory lead on massive CSV projects.
• Documentation & Review: Governed, reviewed and authorized validation deliverables, Standard Operating Procedures (SOPs), and site-wide compliance frameworks.
• Risk & Data Integrity: Directed system Lifecycle processes covering change control management, configuration structures and electronic record backup verifications.
• Investigation Leadership: Facilitated deep-dive root cause analyses, GAP investigations and proactive remediation planning to resolve systemic anomalies.
• Laboratory Calibration: Managed complex laboratory commissioning, instrument qualification tracking.
• Audits: Audit exposure (USFDA, EMA, TGA, MHRA, Health Canada & customer audits).
• Laboratory Excellence: Supervised analytical method development workflows, stability research programs, and chemical inventory metrics to preserve premium operational standards.

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)

Quality Control Intern at BIOCON Ltd. (2010-06 – 2010-09)

Acquired immersive foundational experience in Pharmaceutical quality controls technical sample testing and data validation 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 (Diploma in Computer Application) – Manipal University