Melissa El Khouri is BioCina’s Head of Quality. Melissa drives for right-sized quality processes, to maintain the highest quality standards and cost-effective service. Melissa has over 10 years of experience in Quality, including previous roles at Hospira and Pfizer.
Her strong engineering and validation technical skills support her quality decision making and support of management of BioCina’s CDMO client portfolio.
Melissa has experience in designing and managing quality management systems that meet the regulatory requirements of highly regulated markets including, but not limited to, USFDA, EMA and the Australian TGA.
Melissa managed a successful USFDA Pre-Approval Inspection (PAI) in 2019, that resulted in a product approval in 2020.
Melissa holds a Bachelor of Pharmaceutical Engineering, from the University of Adelaide and a master’s degree in Engineering Management, from the University of Technology Sydney. She also volunteers as a committee member and representative for South Australia of the PDA Australia Chapter.