Anu Ramesh Email & Phone Number

A quality management professional with 23 years’ experience in the TGA regulated multinational pharmaceutical, Med Device and FMCG industry. Proven track record of managing the team of quality professionals and motivating them to consistently exceed targets. Able to drive bottom line results throughout the organisation. Good team player in working with multi departments. Additionally recently with Veeva Systems experience gained sound knowledge of Cloud software which supports Life Sciences Industry for Quality, Regulatory and Clinical areas.Leadership Skills• Demonstrated leadership abilities including excellent interpersonal, communication, managerial and organization skills.• Recognized by senior management as customer oriented professional with proven negotiation skills• Proactive self-starter with track record of initiative, personal responsibility, ownership of work and reputation for removing obstacles and making things happen.• Strong leader who effectively motivates others and directs top-level strategic corporate initiatives.Technical & Professional Skills• Technical Solution Consulting Cloud Systems software knowledge for eQMS , eTMF and Regulatory systems.• Comprehensive working knowledge with TGA and TGA regulated environment. Extensive experience in Quality, Regulatory Affairs and Compliance issues and standards related to pharmaceuticals including a strong understanding of the TGA, FDA, ICH and cGMPs regulations. • Lead Regulatory & corporate audits to successful outcome• Managed Supplier Quality and Third Party Manufacturing to ensure corporate & regulatory requirements are met• Ability to carry out risk assessment to ensure higher state of control in the Pharmaceutical manufacturing and make recommendations to management based on the results.• Served as subject matter expert on internal/external teams responsible for global Quality Systems initiatives• Implemented the Enterprise Management Systems for Quality and created a sustaining culture of Problem Solving and Continuous Improvement • Established a culture of Right First Time to improve the turnaround time• Extensive knowledge in computer/programming skills• Designed & managed real time metrics & KPI’s for the local manufacturing and distribution entity

Listed skills include Pharmaceutical Industry, Change Control, Quality Auditing, Validation, and 4 others.