Nithya Ka

Background

About Nithya Ka

Compliance and Process Consultant with over 11 years of experience in performing Quality Assurance activities and ensuring compliance with the quality management system which includes application development and management, auditing for quality standard compliances, compliance consultation, process definition and documentation I take a global lead in ensuring the regulated systems are in compliant use in clinical trials and pharmacovigilance for a major pharmaceutical industry. To democratize the highest of standards, I actively lead teams and direct them in ensuring that the development and implementation of the computerized systems is conducted in a pragmatic and risk based approach without compromising the regulatory requirements such as GAMP, 21 CFR part 11, and ICH guideline. Responsible for the definition of effective quality management procedure and perform internal quality reviews/periodic reviews/audits to assess the system performance against the same standards. Leverage the acquired skill to bridge the gap between business expectations and IT commitments by communicating the demands of the regulatory expectations while understanding the the obstacles that commonly impact projects and delivery. Ensuring that the regulated IT systems are in compliance with the defined PSPGs and risks are proactively identified and managed, monitored the compliance of the applications/services through scorecard and dashboards, guided them on processes where they need to improve. Compliance parameter covered from an application standpoint involves: • Change Management • Incident/Problem Management • Exception/Deviation Management • CAPA Management • Archival Management • Process Audits Management KEY SKILLS: • Expert in end-to-end compliance thus ensuring License to Operate • Critical Thinking – In alignment to industry trend and pharma landscape • Global Influencer – Influence global stakeholders with practical ways of working • Adapting to change – Assimilating to any internal/external changes and ensure non-stop BAU • Self-driven Professional – Motivator who believes in team win! • Hands-on experience in leading projects/BAU to ensure compliance of High-Risk Tier IT applications impacting GCP, GMP & GPvP • KQI Governance / Dashboard for Leadership Teams in covering process control statuses, high-risk features and assurance plans • Develop and manage high performance team at par with global standards • Practice usage of right tools for managing compliance in DevOps ways of Working