Lee – Orion GxP consuting

Women in Industry – Inspire Inclusion

Lee — Thu, 07 Mar 2024 09:13:02 +0000

International Women’s Day is about empowering women and the work they do. To strive for a world free from bias, stereotypes, and discrimination. This year, in 2024, the theme for International Women’s Day is “Inspire Inclusion”. It is about the importance of creating an inclusive society where women are valued, respected and empowered to participate fully in all aspects of life.

As a woman, I am very interested in seeing how this is accomplished in the world of business. My name is Lee Maxwell, and I am the Business Manager at Orion GXP Consulting. By day, I manage the business and admin in Orion GXP Consulting, and by night, I am currently studying to be a Criminal Psychologist. I find it very hard sometimes to participate in all aspects of life. Sometimes, when work is busy, I find it hard to have time for family and study; likewise, when assignments are due, family and the house are put on hold for a day or two to complete everything until I can get up to speed and get things back to normal. I consider myself extremely lucky in the work I do in that I have a very supportive family and a very understanding company that helps me juggle everything I have to do each day to make sure it gets completed. Because of this, I always feel valued and respected in all aspects of my work and study.
Here at Orion GXP Consulting, we are very proud to have a predominantly female team, and we asked a couple of members of our team to tell us about what it was like working in the industry as a woman and what their day looked like.

A day in the life of – Kay Flahive

No two days are the same when working as a contract QP/QA consultant with Orion GXP. One day, you could be working on Clinical Trial releases into Europe for an Investigational Medicinal Product. This involves preparing the product specification files, review of the batch records, shipping data, deviations, change controls, etc and liaising with the project manager/sponsor on various quality/regulatory queries. The next, you could be delivering quality-related training, auditing a client site, working on a QMS improvement project, or providing general QA/Reg support on various topics (e.g. technical agreements, submitting a variation to MIA licence), or a mix of the above.

The work I am doing in Orion GXP has allowed me to take the knowledge and skills I have amassed with my industrial experience to date and further build on this as each new situation, project, query, etc arises. As well as the work being very interesting and varied, it is also very rewarding knowing that you are part of the process of assessing new and cutting-edge treatments.

I also love the flexibility and improved work-life balance it provides. I moved from a 5-day week fully on-site role (that involved a 5:30 am rise to avoid traffic in the Jack Lynch tunnel ) to a 4-day week remote role, which allows me to drop/collect kids from school, walk dogs at lunchtime, while still delivering on the client’s needs.

Now, over to one of our UK team members, Nim Tarry!

A day in the life of – Nim Tarry

As an Associate Director and consultant RP/ RPi (in the UK) who works full time, 5 days a week, my clients are at different stages of the processes of WDA(h) licenses in full swing or applications that need submitting. Their needs are different, some may need QMS support, while others need a QM writing from scratch, I may be needed to provide training and auditing support, so no day is the same and it can feel quite crazy.

My role requires me to be flexible and adaptable, and being flexible is great for me, as I can carry out my work so that it fits around my home life too and vice versa, which creates a fantastic work-life balance for me and my family. I am able to take the time when I need it, take a breath and walk my crazy cockapoo puppy. This, for me, is great with the stresses and demands of the role to balance out.

Being a part of the Orion GXP consulting team allows me to feel empowered; things many women would have had to fight for in the past are now just a part of everyday living and working. Being in a world where there is no prejudice for being a woman and a woman at work is a long way away from where women in the past would have been, and the support received at Orion GXP consulting for its workforce of women just re-enforces this.

Thanks so much to Kay and Nim for sharing your thoughts and for being part of our fantastic and growing team!

Why is good manufacturing practice so important in the Pharmaceutical industry?

Lee — Sun, 29 May 2022 15:08:39 +0000

GMP regulations require that all manufacturing processes must be documented and can be traced from beginning to end. Complying with GMP guidelines makes sure that companies produce high-quality medicinal products for patients and ensures that risks are minimised in production. For example, GMP minimises the risk of contamination of products, incorrect labelling, and insufficient or excess active ingredient, which could cause adverse reactions or a lack of efficacy.

In this article, I would like to outline the main components of Good Manufacturing Practice (GMP), and how the drug manufacturer must incorporate these into their operations.

Firstly, being able to ensure that the highest quality materials are used through a robust vendor management process is critically important. This results in high-quality end products and having good GMP standards as part of the supplier approval and procurement processes ensure that the products are consistently manufactured to deliver high-quality medicines.

A sound Quality Management System (QMS) ensures that all of the processes carried out in the manufacturing plant such as goods inspection, QC analysis, complaint handling etc., are clearly documented and managed consistently. By obtaining GMP certification, companies verify that the QMS procedures comply with their Competent Authority regulations and meet the highest product quality standards.

Manufacturing sites and laboratories must be maintained to a high standard with regular qualification and calibration of all equipment and machinery. They should ensure that they have a comprehensive internal audit program and conduct inspections to ensure that products are consistently made to a high standard and are tested to ensure their safety and effectiveness.

Not following some of these basic GMP requirements could result in products or pharmaceuticals being recalled which not only impacts patient lives but also the company’s reputation and costs. When implementing a self-inspection program it is a good idea to check that company sites are GMP compliant on a regular basis. Doing this ensures that the site is always up to the latest cGMP compliance standards, i.e. the most current guidelines issued.

Manufacturing procedures will be scrutinised in a regulatory inspection. All processes and procedures need to be checked and revised regularly to ensure that GMP guidelines are followed and that the technology is up to date. These should be written clearly and straightforward to be easily understood by everyone involved in the process. Not having this in place can lead to mistakes by staff which causes problems in the manufacturing process.

Procedures involved in GMP need to be maintained and followed to show that proper processes are being followed and that there is documentation to show this. This documentation is critical during a competent authority inspection. Each process should be shown in detail from beginning to end, and the manufacturing process must be followed throughout each step. Having the documents laid out like this can be used to help with decision making and training and shows that the process is GMP compliant. Not having this in place could lead to mistakes being made, which in turn costs the company in compliance, time and money.

Lastly, staff and training procedures are vital. Having entirely up to date trained staff is paramount in manufacturing pharmaceuticals and medicinal products. Having this in place ensures the site is GMP compliant, ensuring that they are helping to create safe and high-quality products.

Having your site GMP compliant is mandatory for manufacture and distribution in the EU. This shows that the products being made are kept to a high standard in a top-class facility with fully up to date training for staff and procedures and protocols that can be easily followed and are reliable. This ensures good business practice, and not having this in place can have an adverse effect on the company’s reputation. In addition, it is designed to minimise risks that cannot be eliminated in final product testing and shows that each time the product is manufactured it is to the exact same standard as before.

Here at Orion GXP Consulting we have consultants on hand with decades of experience in Quality Assurance and ensuring our clients manage their operations to the highest GMP standards. So whether you need revisions to the QMS, assistance with the audit program or help with facility qualification, we can assist.
To discuss your needs further contact us at info@oriongxp.com or call +353 7198 10101.