Pharmaceutical Development

Helen – Lead GxP Archivist

I took up the role of Documentation Officer in the Quality Assurance Department in 2005, with responsibility for updating the majority of our critical documents. I covered a number of different processes in my early PBL career which meant I was able to progress into the Validation department, where I stayed for 3 years and helped with gaining licensure for Erwinaze in the USA, before then moving to the Archive Service.

Being a Scientific Archivist is slightly different to what most people traditionally perceive of as an Archivist as we are not looking after century old manuscripts.  Instead, the main aspect is data integrity and making sure that the records for the various products that PBL manufacture are kept safe; so that they are all there should anyone ever need to refer back to them. We currently have about a 100,000 records (ranging from one to thousands of pages each) in about 100 cubic meters of storage space so it is no small undertaking for the team to keep track of every piece of paper.

Currently 99% of the day to day records are still on paper because it is a known quantity and a safe format, but we have also implemented an Electronic Quality Management System, so we are moving towards the provision of electronic records.  As a well as being the Lead Archivist I am also one of the System Administrators for that software and so balancing my workload is a constant juggling act.

Organisation is a critical aspect of my job. We manage hundreds of thousands of pieces of paper, so if anything is out of sequence there is a risk that we may not be able to find the vital piece of data required. This is particularly important when it comes to regulatory inspections, but that is a challenge I enjoy. We have a ‘backroom’ who deal directly with the requests, but I am in the lucky position to able to help staff receiving those requests on the ground.  Inspectors will sometimes ask esoteric questions like “why did you come to do it that way”, I can then help try to find where the information is recorded to prove how we came to a particular decision, which I enjoy more than retrieving facts and figures which we can access much more easily.

Helen’s Tip

I have an Arts Degree and I never thought that I would end up anywhere near pharmaceuticals in a million years. A science background isn’t necessarily a requirement for working for the company, in fact most of us in the Archive don’t have that so don’t rule it out if you are considering applying for a job here.

Other interests

Outside work I enjoy the performing arts and also more recently, genealogy. I’ve traced my family tree as far back as the 16th Century on some of the branches. It is a rewarding hobby, but currently my two year old daughter is keeping me busy, so delving further into my history may have to take a back seat for a while.