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.
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EDUCATION:
- Executive MBA (Business Analytics), NMIM
- Bachelor of Science, Microbiology, Calcutta university
CERTIFICATIONS:
Agile Certifications
- SAFe5 Agilist
CSM (Certified Scrum Master
Testing Certifications
- AISTQ (Test Manager)
ISTQB
ASSOCIATIONS:
- PV Consultant, Eliquent Life Sciences (April 2025 – Present)
- Managing Consultant, Truliant Consulting (April 2024 – March 2025)
- Quality and Compliance Manager, Genpact (Feb 2016 – March 2024)
- Quality Lead, Intelegencia (March 2010 – Jan 2016)
- Quality Analyst, Cognizant Technology solutions (Nov 2007 – Oct 2009)
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- Software Professional having 15+ yrs of extensive experience in Quality Management, Quality Assurance, Quality Control, Business Analysis, Computer System Validation(CSV), AI/ML Validation, Regulatory Compliance working in a highly agile environment.
- Specialization across industries-Life Sciences(Pharmacovigilance)- Intake/Case Management/Signal Management and Detection.
- End to End Validation as UAT/PQ Validation Lead for Signal Management and Signal Detection for large pharma clients.
- Significant Experience in gathering business requirements/translating stakeholder requirements into different deliverables such as functional specifications, use cases, user stories, workflow/process diagrams, data flow diagrams.
- Comprehensive knowledge of CMM standards, 21CFR Part 11 standards, GxP and GAMP guidelines.
- Successful track record as QA Manager ensuring product goals and high quality standards are met throughout the product lifecycle.
- Handling SOC, Internal and Client Audits, Quality Management System (QMS), Change Management, Computer System Validation of regulatory projects.