Mitali Jaiswal

• Greenfield & Brownfield Projects in which Managed project activities related to
facility design, engineering, equipment installation, commissioning, and validation.
• Strategic business development and client relationship management,
collaborating with vendors, stakeholders to deliver project milestones on
schedule and within budget.
• Overseeing comprehensive compliance projects, ensuring adherence to global
regulatory standards and Good Manufacturing Practices (GMP).
• Managing end-to-end project lifecycles for pharmaceutical, food, and nutraceutical
sectors, focusing on technical troubleshooting and process engineering.
• Developing and implementing Quality Management Systems (QMS) and
documentation to ensure operational excellence and regulatory approval for industrial
facilities.

• Managed core Quality Management System (QMS) elements to ensure site-wide
adherence to global regulatory standards and internal quality benchmarks.
• Coordinated training programs, SOPs, cGMP guidelines, and operational procedures.
• Led technical investigations for process and systemic deviations, Root Cause
Analysis (RCA) to identify underlying triggers and prevent recurrence.
• Developed and tracked Corrective and Preventive Actions (CAPA) and evaluated
Change Controls to ensure proper modification.
• Applied Quality Risk Management (QRM) principles to identify potential risks and
implement mitigation strategies.
• Authored and reviewed critical documentation, including SOPs, investigation reports,
ensuring audit readiness.

• Executed core production and packaging operations with a focus on operational
efficiency and regulatory compliance.
• Monitored daily production schedules to achieve 100% of the monthly plan.
• Supported equipment validation and new product launches by monitoring trial runs
and validation batches.