Akhilesh Nawade

Ensured comprehensive regulatory compliance for products and services with ISO 9001, US FDA 21 CFR Part 11, and EU Annex 11 standards.

Managed the end-to-end Quality Management System (QMS), streamlining SOP reviews, change control, and documentation processes.

Conducted internal quality audits, authored detailed plans and reports, and drove continuous improvement through effective follow-up actions.

Maintained key performance indicators (KPIs) to monitor operational effectiveness and supported tool assurance activities, including inventory reviews, risk assessments, and tool validation.

Monitored all Agile projects, leveraging metrics and data to identify continuous process improvement opportunities and innovate solutions.

Coordinated with stakeholders to align project management activities with management strategies and goals, enhancing collaboration.

Evaluated existing business processes, identifying and mitigating risks or gaps in process adherence through actionable plans with functional teams.

Analyzed and identified process flow gaps against ISO 9001, ISO 20000, ITIL, CMMI, and Agile standards, implementing solutions for internal and external customer standardization.

Led PMO activities for improvement projects, facilitating training plans, and mentoring resources to develop expertise in new business processes and tools.

Ensured efficient and effective adherence to the Quality Management System (QMS) and SEPG processes across the organization.

Developed and designed end-to-end project lifecycles, implementing quality management strategies and plans, including timescales, integrated with the organization's business plan.

Maintained Project Management Plans, providing monthly updates to higher management and proactively flagging issues for timely resolution.

Provided QMS optimization solutions by automating artifact preparation and updates within the ALM tool, enhancing efficiency.

Delivered quantitative and predictive analysis data for CMMI Level 4 practice, developing robust Process Performance Models (PPM).

Implemented Agile Scrum across the organization, driving and coaching SCRUM Teams to enhance project delivery.

Managed SCRUM Projects, conducting daily stand-ups and collaborating with Product Owners to prioritize backlogs effectively.

Mitigated SCRUM team issues and managed problems, reporting team activities within SCRUM frameworks to ensure smooth operations.

Conducted data collection and analysis for projects, publishing organizational-level project baselines to guide decision-making.

Performed Root Cause Analysis (5 Whys/Fish Bone Analysis), planning and executing IQA activities, and ensuring closure of Non-Conformities.

Managed key initiating, planning, executing, controlling, and closing processes, developing and implementing quality plans to foster team ownership.

Deployed a robust Quality Management System and ensured Quality Compliance at the project level.

Developed a Risk Management framework at an offshore location, partnering with cross-functional teams for timely and effective remediation.

Prepared due diligence reports for Project assessments, introducing new systems and procedures to drive defect identification and reduction.

Performed Internal Quality Reviews and Project Level SLA Reviews for all application management services, ensuring high standards.

Facilitated Project Managers in preparing Process Performance Models and setting up Project-level KPIs to achieve Organization Level Objectives.

Implemented 'Light projects' at various Business Unit levels, contributing to organizational efficiency and process standardization.

Performed Effort Variance Analysis and provided recommendations for estimation process improvements, publishing Trend Analysis.

Identified process gaps, analyzed root causes, and tracked them to closure, enhancing overall process quality.

Contributed to enhancing the organizational Quality Management System (QMS) in coordination with the SEPG team.

Managed and analyzed ESOP-based factors to inform strategic reports and business decisions.

Managed Business Wealth Creation Reports, including MIS and Ad-Hoc reports, providing critical insights.

Provided consulting services to ESOP-based clients, advising on wealth creation strategies.

Created comprehensive Analysis Reports (ESOP-Factor) to support client understanding and decision-making.