Quality Assurance professional working in pharmaceuticals with comprehensive knowledge and strong
communication skills, understanding of cGMP, Regulatory Compliance and Regulatory inspection. Proven
leadership skills involving managing, developing and motivating teams to achieve their objectives. Dedicated
to maintaining high quality standards. Able to work on own initiative and as part of a team.
Aware of Regulatory Guidance(s) and requirements USFDA, EU: Compliance and Product Filing.
Need to lead below functions:-
Process Validation
Cleaning Validation
Quality Management System
Risk Management
Documentation and Data Control.
State / Central FDA Licencing
Hosting Regulatory inspections and customer audits.
Audit management and Auditing skills
Analytical QA review and activities.
