Anamika C.

About Anamika C.

Seasoned IT and Life Sciences professional with 18 years of experience, including 16+ years of deep expertise in Computer System Validation (CSV), Governance, Risk & Compliance (GRC), and Quality Management. Proven record of leading global validation programs, managing regulatory compliance initiatives, and ensuring GxP adherence for top-tier pharmaceutical clients including Novartis, Novo Nordisk, Roche, Catalent, UCB, and Novartis-Alcon.Skilled in end to end CSV delivery across diverse methodologies and regulatory frameworks such as 21 CFR Part 11, EU MDR, FDA guidelines, Annex 11, GAMP 5, and GDPs. Strong background in authoring, reviewing, and approving validation deliverables including IQ/OQ/PQ, CQ, DQ, URS/FRS, Validation Plans/Reports, System Procedures, and Release documentation.Expertise spans CSV Validation Management, IT CSV execution, Project Quality Management, auditing, SOP governance, and regulatory assessments. Adept at leading independent quality reviews, performing risk-based assessments (RCA, FMEA, FRA), driving compliance audits, and ensuring alignment with organizational SOPs, WIs, and regulatory expectations.Experienced trainer, assessor, and mentor with a strong focus on quality culture, adherence, and continuous improvement. Hands-on experience in Agile and Waterfall environments, test strategy development, paper-based testing for EU MDR, defect management, and stakeholder collaboration. International exposure includes extended assignments in Germany for requirements gathering, planning, and release management (2009–2013 & Feb 2023–Oct 2024).Recognized for strong analytical skills, process mindset, regulatory depth, and the ability to drive compliant, efficient, and audit ready solutions across global Life Sciences programs.Key Responsibilities• Leading Quality Management for a large pharmaceutical program with 250+ team members, ensuring governance, regulatory compliance, and audit readiness. Managing a compliance team with 5 direct reportees and 10 compliance managers.• Authoring key CSV and compliance documents including: o Product Increment (PI) Plan & PI Reporto Release Plan & Release Reporto Data Migration Plan & Reporto Validation Plan, Reporto Qualification Plan, Reporto Project Controlled Maturity Assessment• Driving Agile project execution while ensuring alignment with CSV processes and Agile aligned CSV SOPs.• Performing Change Impact Assessments, maintaining decision logs, and supporting compliance-driven sprint planning & execution

Experience

1. Senior Consultant Business Consulting

   Infosys Consulting

   Nov 2024 — Present · IN

   Successfully strengthened quality governance across a complex, multi tower Life Sciences program.Played a critical role as part of the Client’s Internal Assessment Team, performing internal audits and authoring audit reports.Improved audit readiness and compliance tracking through structured assessments and proactive risk mitigation.Enabled smooth Agile and compliance integration, ensuring delivery teams adhered to CSV and regulatory expectations.Designed and delivered training programs, capability matrices, and onboarding frameworks to uplift team competency in validation standards.Conducted hiring assessments, interviews, and knowledge transition planning; created reverse KT docs and captured lessons learned to improve delivery maturity.Client Engagement, Stakeholder Management & CollaborationPlayed a key role in Program Increment (PI) planning for 250–350+ member programs, ensuring compliance integration into Agile execution.• Strengthened cross functional collaboration by bridging gaps between onshore teams, technical SMEs, QA stakeholders, and delivery teams.Testing, Validation & Defect Governance Excellence• Directed full testing lifecycles — functional, system, regression, migration, and UAT — ensuring defect free, compliant system releases.• Oversaw test strategy, test design, execution governance, defect triage (RCA), defect lifecycle management, and ensured timely closure of high risk issues.• Validated complex system modules including audit trails, data migration, configurations, and application security elements across global pharma ecosystems.Quality, Compliance & Regulatory Leadership• Spearheaded end to end GxP, CSV, and regulatory compliance initiatives across global Life Sciences programs, ensuring zero audit escalations and consistently meeting FDA, EMA, and EU MDR expectations.• Championed pre and post execution quality governance, strengthening adherence to 21 CFR Part 11, Annex 11, GAMP5, and internal QMS frameworks.

Education

• Indore Institute of Science and Technology

  Bachelor’s Degree, Computer Science

  2003 — 2007