Mark O'Connor

Technical Manager, Validation Sciences, AstraZeneca

Mark’s current role in AstraZeneca's Product Robustness Centre of Excellence (CoE) is to embed the validation lifecycle and drive improved global technical standards for process validation. In AstraZeneca, Mark is the global lead for Continued Process Verification (CPV). He is the lead author for the cross-functional quality standards and guidelines for CPV, manages the process maturity across AZ and chairs a global network of CPV data analysts from AZ’s production facilities. Mark is responsible for the Product Robustness data strategy and chairs the process intelligence governance team in AZ. A Six Sigma certified Black Belt he has a passion for coaching, problem solving and process robustness. As an active member of the International Society for Pharmaceutical Engineering (ISPE); he has delivered podium presentations at ISPE conferences, co-chairs the PAT & Lifecycle control strategy CoP and is member process validation team. Mark joined AZ as an analytical development scientist with an interest in Process Analytical Technology (PAT). Mark transitioned to AstraZeneca’s Operations function where he was responsible for process-scale up, optimisation and an integral part of the start-up team accountable for validation of a new sterile manufacturing facility in the UK.