Orion GXP Consulting assists our clients by placing expert quality and regulatory contract professionals, tapping into our network of industry subject matter experts, including statutory roles such as EU Qualified Person and Responsible Person.
The variety that comes from working in consulting is one of the things that makes it so rewarding, with each client resulting in a different experience.
This week we spoke to Anne Johnston, Clinical EU Qualified Person, about her roles working with Orion GXP consulting and the types of projects she works on.
What influenced your decision to join Orion and make the jump to contracting?
Joining Orion allowed me to utilise my QP qualifications and expand my knowledge of different QP roles. It also gave me the opportunity to have an improved work / life balance as I went from working a 5-day week to a 3-day week.
What types of projects do you get to work on?
In the time that I have been in the position I have worked on Clinical Trial releases for Investigational products, commercial comparator products and placebos.
I have worked on QP declarations, variations to MIA licences and the importation into the EU of products to be used in clinical trials. The preparation of product specification files and supply chains for various clinical trails is also a major part of my role.
The work is very interesting and it is rewarding knowing that you are part of the process for assessing new and cutting edge treatments.
What does a typical day look like for a QP?
In my role a typical day will be attending meetings and answering various quality questions with regards to importation of products, labelling requirements for clinical trials and documentation for products being used in the CT. Also I prepare the product specification files for new clinical packaging projects, and work with the sponsors to obtain approval of the master batch records.
Other duties include review of shipping temperature records, deviations, change controls and SOPs.
Each day brings a new question that needs to be researched and there is definitely never a dull moment!
When you first started as a contract QP, what surprised you as being important in this role?
The contract QP role is a central part of the project team, and I was surprised at the advisory aspect of the job. Being available for questions and providing assurance that each project will meet its deadlines is important to the sponsor and is an important function of the contract QP.
Do you have any tips for people who want to pursue a career as an EU Qualified Person?
It can be tough sometimes to leave a permanent role to work as a contract QP. But for anyone who enjoys learning new processes and working on different projects then the contact QP role can offer this opportunity. An improved work / life balance can be achieved in the contract QP role.
Thank you so much, Anne, for giving us your insights and for all the hard work you do for our clients!
We are always looking out for new clients and talented industry professionals to join the team, including permanent employees and freelancers.
If you wish to avail of our services or to be considered for contract and consulting positions, please email us at info@oriongxp.com, or set up an appointment to network directly with us, and help us widen our client and talent pool!