Jayita Chakraborty

Pharmacovigilance & Safety Practice

OVERVIEW

FOCUS AREAS

More than 15 years experience in IT/Software Industry with a strong background in Quality Management, Quality Assurance, Agile methodologies, Computer System Validation (CSV) and regulatory compliance within the Pharmacovigilance domain.

Business Requirement Understanding and Gathering / Providing Solutions
Quality Management
End to End Validation / CSV
Participating in Business transformation initiatives
Increasing Operational efficiencies

As an experienced Software Professional, Jayita Chakrabborty specializes in Computer System Validation (CSV) and regulatory compliance within the Pharmacovigilance domain. With a strong background in Quality Management, Quality Assurance, and Agile methodologies. She has successfully led validation efforts for global life sciences organizations, ensuring adherence to industry standards such as 21 CFR Part 11, GxP, GAMP, and other regulatory guidelines.

Jayita is an experienced Software Professional specializing in Computer System Validation (CSV) and regulatory compliance within the Pharmacovigilance domain. With a strong background in Quality Management, Quality Assurance, and Agile methodologies, Jayita has successfully led validation efforts for global life sciences organizations, ensuring adherence to industry standards such as 21 CFR Part 11, GxP, GAMP, and other regulatory guidelines.

Jayita’s expertise includes managing validation projects for PV systems, handling internal and external audits, implementing robust Quality Management Systems (QMS), and driving end-to-end validation strategies for both traditional and AI/ML-based solutions. Jayita has a proven track record in gathering and translating business requirements into clear validation deliverables, fostering cross-functional collaboration, and mentoring teams on Agile best practices to enhance compliance and delivery efficiency.