Emily Baker

Background

About Emily Baker

A Validation Manager with a Bachelor of Science degree in Pharmaceutical Sciences and with over 16 years of experience accustomed to working within strict regulatory quality environments. I am a highly motivated individual who possesses the ability to lead projects and change management with a team and or independently, with a very strong work ethic for achieving results whilst maintaining good relationships at all levels within the organisation. I have extensive experience in Project Management, Manufacture Processes, Assays/Equipment/Process/Computer systems Validation and control of biological products within GMP and GDP environments. I am a person who is always looking for new challenges where I can develop my skill set further both personally and professionally. Experienced with risk assessment development and creation/management of new QMS processes. Cross functional team leader working across global team function both with internal and external customers supporting technical transfer activities for registered and clinical trial products. End to end change management experienced with knowledge and experience with regulatory requirements/submission packages for license updates with track record of successful approvals. Influenza, API formulation, Blow Fill Seal, tablet formulations, sterile Prefilled syringes, Stability, Quality Control assay development experience attained throughout my career.