Harsha Vardhan Gupta
Head Biologics Quality - Kwality Pharmaceuticals | Biopharmaceutical specialist | Driving Compliance, QMS, Biosimilar Process Development and Excellence | Ex-Biocon Biologics, Zydus, Hetero Biopharma, Gland & Hetero Labs
- Role
- Head Qa - Biologics at Kwality Pharmaceuticals Limited
- Location
- Amritsar, PB, IN
- LinkedIn followers
- 500 followers
About Harsha Vardhan Gupta
As a seasoned Quality Assurance Leader in the biopharmaceutical industry, I bring over a…
Experience
Head Qa - Biologics
Kwality Pharmaceuticals Limited
Aug 2023 — Present · Amritsar, IN
Governing regulatory submissions for RCGM, CDSCO, and health authorities across Middle East and LATAM countries. Playing a key role in ensuring compliance with local regulatory standards for biosimilar products. Collaboration with the manufacturing team on process development for new biosimilar molecules, ensuring regulatory alignment and quality oversight during validation stages. Spearheading internal audits, vendor qualifications, and audit readiness for external inspections, ensuring post-audit compliance with corrective actions. Supervise the establishment of a new biosimilar manufacturing facility, integrating robust quality management systems for smooth regulatory approval processes.
Education
SRM IST Chennai
Master of Technology (M.Tech), Biotechnology
2008 — 2010
Jawaharlal Nehru Technological University
Bachelor of Technology (B.Tech), Biotechnology
2004 — 2008
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