Nicola Kiernan

BSc Applied Biology 1990

Manufacturing Quality Manager and Trainee Qualified Person at Sartorius based in BioCity Scotland

Nicola Kiernan 680

Tell us in more detail what your role entails, what challenges you currently face, and how you are finding ways to cope.

In my current role I am responsible for the Quality Department on the GMP Manufacturing site. The Sartorius site is a contract manufacturing site, manufacturing Master and Working Cell Banks for Global Pharmaceutical companies who are developing and manufacturing finished products and medicines. 

I am the named QC person and Site Contact on the site MHRA license thus I have overall responsibility 

I am also a Trainee Qualified Person and am almost through a 2 year training programme with NSF where I aim to be a fully licensed QP by the end of the year.

The challenges facing the industry at the moment is as a result of Brexit. Currently the UK Pharmaceutical Law and Administration is governed by EU GMP. All our laws, guidance and regulations are based on EU Directives and are recognised and accepted in the EU and across the globe. As we leave the EU our systems and processes will no longer be EU based and the UK will be a Third Country and thus will have to build new relationships with the EU and rest of the world using our own standards and practices but I anticipate common sense will prevail and Mutual Recognition Agreements will be put in place. There are many other challenges which the pharmaceutical industry face but from a personal perspective the biggest challenge has been brought about by Covid 19 outbreak where our systems and processes are being challenged almost overnight to cope with social distancing, limiting personnel on site as use of digitalisation for local and global communication while remaining compliant with defined procedures and processes yet ensuring manufacture still happens. As an Industry we cannot impact on the supply chain of medicines, delay development of new medicines or impact on on-going clinical trials so must therefore adapt and change within the realms of compliance and Pharmaceutical Law. 

Do you have a top tip for coping at a time of crisis? Or a few words of advice or support for fellow students and alumni on the front line?

The top tip for coping with challenges is always keeping in mind why I do what I do and that it is for the patient who receives a medicine which somewhere in the supply chain of that product I made a tiny minute contribution to. Being part of the healthcare system, albeit I am not frontline like nurses and doctors, NHS staff and key workers, makes me proud. I come to my work every day and make sure the medicines that are needed on the front line are available. To fellow students, alumni and front line workers I think the time has come where citizens of the world now acknowledge more than ever the noble profession of caring for other people in whatever capacity that may be. I believe we will have changed for the better as a result of this pandemic and the healthcare industry may get the focus and funding it has sadly lacked.

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