Manisha Makhija

Lead Computer System Validation (CSV) Consultant with over 18 years of experience in Validation and regulatory compliance (GxP, SoX) across healthcare, and life sciences customers (GE Healthcare, Johnson& Johnson, Boston Scientific, Takeda Pharmaceuticals, Pfizer). Strong background in validation of complex enterprise platforms, CRM applications, Cloud Solutions, Transformation using Waterfall and Agile methodologies for audit readiness, process improvement, and cross-functional quality support.

Quality Compliance and Assurance as CSV Consultant at Tata Consultancy Services Ltd (2011-09 – 2026-07)

Handled quality compliance and assurance duties with a focus on Computer System Validation (CSV) within the company. This role required a comprehensive understanding of validation processes and compliance standards to support client projects effectively. Responsibilities included overseeing validation activities, ensuring adherence to regulatory requirements, and providing expert guidance to project teams.

Quality Assurance at IBM (2009-11 – 2011-09)

Managed quality assurance tasks, emphasizing the importance of maintaining high standards in product and process quality. In this position, the focus was on identifying potential issues, implementing improvements, and ensuring products met customer expectations. Collaborated with cross-functional teams to support quality objectives and optimize procedures.

Quality Assurance and Compliance at Birlasoft Ltd (2006-08 – 2011-08)

Oversaw quality assurance and compliance initiatives, ensuring that projects adhered to established standards and regulations. The role involved conducting execution, documenting processes, and implementing corrective actions where necessary. Worked closely with teams to promote a culture of quality and continuous improvement.

Bachelor of Engineering in Information Technology – Rajiv Gandhi Technical University