Education and Professional Membership
- BSc (Hons) Chemistry
- Chartered Chemist
- Member of the Royal Society of Chemistry
- Member of TOPRA (The Organisation for Professionals in Regulatory Affairs)
Indira has over 25 years experience in the pharmaceutical industry and is a Qualified Person (through the permanent provisions). She has held senior Director level appointments in both Quality Assurance and Regulatory Affairs roles with US, EU and Japanese multinational and contract manufacturing companies working with both development and commercial products. Having set up a consultancy in 2004, she has considerable experience working with clients to define appropriate QA and Regulatory strategies for major initiatives such as mergers and acquisitions, new product/process development and significant organisational and operational change management programmes.
Recently with Iolite
Indira has significant experience in taking on senior Interim Management roles, guiding companies through periods of significant change or activity. This has involved working with virtual and contract manufacturing organisations. These roles often interacting with the Regulatory Agencies and other senior stake holders to manage change management initiatives.
Indira has recently worked on major GMP and GDP Inspection preparation and remediation projects.
Email Indira Walker