Mark Mccall Email & Phone Number

Newry, Gb

Dublin City North

Armagh, Northern Ireland, United Kingdom

I write training notes for people that I hope will benefit those that want to become QP's and those that have too lively an interest in Quality Assurance.

Dundalk, County Louth, Ireland

Newry, Northern Ireland, United Kingdom

Newry, Northern Ireland, United Kingdom

Newry, Northern Ireland

Responsible for day to day Quality Assurance and GMP compliance across multiple aseptic manufacturing suites with Grade A primary manufacturing environments in Grade B cleanrooms. I lead investigations of compliance deviations and propose and impliment corrective and preventative actions. The suites are VMD and FDA auditable with regular media validation programs and manufacture multiple complex antibiotic products for customers across the world. I undertake ongoing Quality Assurance authorisation of Standard Operating Protocols, Risk Assessments, Change Control Processes and Out Of Specification and Out of Trend Investigations. I regularly develop experimental and validation protocols to support investigative actions and enhance production efficiency in a compliant manner based on lean manufacturing principles.

Loughborough

I worked within the Wolfson School of Mechanical, Electrical and Manufacturing Engineering. I lead a team of multidisciplinary researchers based in the Centre for Biological Engineering at Loughborough University. The team focus on the development of scientific and engineering solutions for adherent cell based therapy manufacture. In particular, we addressed the challenges of scalability and high cost of goods in cell based therapies. We focused on pluripotent and neural lineage product development and had developed novel technology that enabled continuous control of exponential growth in a scale friendly format. This system is currently patented and available to industrial partners for trial.

My research addressed the lack of understand in cost of goods for regenerative medicines - with a particular focus on cell therapies. I have also developed a new bioreactor platform that has the potential to reduce the cost of expanding anchorage dependant stem cell by over 85%

Doctor Of Philosophy (Phd), Manufacturing Regenerative Medicines And Cell Therapies

Bachelor Of Science (Bsc), Physics With Medical Physics, 2:1