Mark O'Connor

Mark is a Technical Lead and Production start-up manager responsible for the start-up of a new primary packing facility in AstraZeneca in the UK. He leads multi-disciplinary team responsible for the validation and associated Operations start up activities for a state-of-the-art aseptic syringe assembly line through to stable commercial supply. Previously, Mark was the global lead for Continued Process Verification (CPV) and the lead author for the cross-functional quality standards in AZ. He managed the process maturity, led the associated data strategy and chaired the global network from AZ’s production facilities. Mark has an MSc. in Analytical Chemistry and held various development and manufacturing roles in AZ. A Six Sigma certified Black Belt he has a passion for coaching and process robustness. As an active member of ISPE; he has delivered podium presentations at ISPE conferences, co-chairs the PAT & Lifecycle control strategy CoP and is member process validation team.