A calm person by nature from North Jutland in a fast–paced business

This is how a description may sound when it is given by Gitte herself. The Life Science industry is a fast–paced industry, and if you want to enter the industry here in Denmark, then the Copenhagen area is where it is mainly done.

Or at least it used to be, and that is why Gitte, in her young days, also moved to Copenhagen to follow the trend, as she describes it herself.

Quite quickly she entered the pharmaceutical industry and the quality area in particular caught her interest. Her career took off in Lundbeck and later in NNE. Gitte had a sense of quality, and thus – quite extraordinarily – became the first female speaker at a conference in India, held by ISPE India, where she gave a talk on risk assessment. Later, she has accumulated a lot of experience as an independent consultant, and recently she was employed by AJ Vaccines, where she worked with communication and negotiated with the authorities, among other things. She provided strategic good and fair reporting, with the aim of ensuring that all licenses were retained in accordance with the change of ownership and the transition from state to private enterprise.

Alongside her career in life science, Gitte has played high-level football in Fortuna Hjørring, and was also selected by FIFA in 1995, when they made their first list of women's referees for football. This has among other things lead her to the European Championships, where she had the honour of being a referee for a final. She says that being a referee is kind of unpopular. It is such a thankless position, where you actually get to use some of this quality and knowing the rules business.


When did you realise that you wanted to work within pharmaceuticals?

Gitte: I come from a really classic working family where mum was at home and dad was a mechanic, but it was always in their interest that I should have a further education. From the start, I have been extremely focused. The first time I came into contact with the industry was already in primary school, where I did an internship at a pharmacy. I thought it was really exciting, producing medicines. Back then, you were allowed to do everything. Today, most of these manufacturing pharmacies do not have a very big production.

In high school I realised that I wanted to study to be a pharmacist, so I just had to get started. While studying as a pharmacist, I came to realise that I would prefer the industry. I wanted to produce pharmaceutical products, and was very focused on production, so I started in a manufacturing position.


When did your focus change to quality?

Gitte: It already changed during my second employment, where I worked in production for approx. 1 year, and from there I came to Lundbeck in QA, where I ended up staying for a period of 7 years. Here I got to try some different positions – all of them in the Q area, and I felt really good about it. In the field of quality you have some established specifications and you go for what you have set out for. You are ambitious, so quality is under control. It means a lot to me.


Where does that come from, do you think?

Gitte: I'm part of Generation X, and I've read that all of this quality is very typical of Generation X. So it may be connected to the way I was raised in the 70s.


Everything you do today, where does it come from?

Gitte: Basically, I grew up with Lundbeck. So all the technical skills within Q – many of them come from there. It was good training. I had some really good colleagues and stayed there for a really good decade, during which we entered the US market for example. When I started there, there were 15 people in QA and when I left them there were 70. I saw how much it meant in a business to enter the US market, and it started my fascination of acquiring some special requirements, and then to enter a new market.

The next step was to become a consultant. I was a specialist when I was in Lundbeck, but coming out and helping other companies was one of the things that caught my eye when I came to NNE. So while my position at Lundbeck was a lot about the technical competencies, then much of my experience which concerns the consulting industry is something that I gained from being at NNE Pharmaplan. There we had many different customers, changing challenges, many different products and a lot of colleagues – also world–wide. In periods I have also been in India and China to work for NNE, which was really exciting. After 9 years in NNE I continued my career in a Norwegian company which produces fish oil and wanted to enter the US market with fish oil as a drug.


After NNE, your employment relationship became of shorter duration and you also worked for a period as an independent consultant. Did something change in the industry or in you?

Gitte: I probably became more aware that when the start-up projects turn into daily operation, the exciting part for me is over. We have made plans and got the site up and running, and we had been approved by the authorities. Now it is running, and then I would like to go home again. In fact, it is also a bit hard on the private side to commute abroad on some of these projects, and typically only stay home in the weekends.

It's become more in and out now. Come in and clean up a business and make a difference, and then I'm really on a new mission. It's probably something that has changed within me. This is about seeking new challenges. I need to be fed more. My husband and I don't have any kids, so my job takes up an incredibly big part of my time. I need to fulfil some goals, so I put a lot of time into my work, and also get a big return in the form of some professional or business goals. And then it is also a matter of experience – you want to expand it and see new things all the time. I'm probably not the type to have a 30th anniversary somewhere. I do it all because I feel like it. You have to be a little picky, I think that is important. Particularly because I put so much energy into what I do.


What would you say is the essence of what you do?

Gitte: You can wake me up at 3 am and then I can recite legal requirements. So it is really just legal business, because there is always a legal text that describes the rules. But of course it is not just a matter of being able to read the text. It is important to be able to understand what lies behind it, because there could be 10 solutions to a problem, and which one is the right one? Here, based on my knowledge and experience, I can help point out the right solution. A solution has some consequences and that is what we advise on. I mean, if you do this and that, then those problems can arise.


Specialist or generalist?

Gitte: I would describe myself as a specialist, but you don't hire me to sit on a project for the next 1.5 years. As a consultant I was typically there to influence a project for a few months – to fertilize the soil or drive it in the right direction or to make some changes.


What is your role here at AlfaNordic?

Gitte: For example it is about seeing the dinner dishes in a new light. I mean, what is dished up. It is always very exciting to enter a new company, and many times you can also see that there are always some routines that are turned on. It happens everywhere – and to everyone, so sometimes you just have to be awakened, shaken and challenged if maybe you should try something else. And then maybe looking a bit into the future. What does the consulting industry look like in the future? At least I have an opinion on that, so I think that's also one of the reasons why I've been invited inside.


What kind of tasks is AlfaNordic particularly good at in terms of quality?

Gitte: A typically exciting task for AlfaNordic is one where you, as a company, may be in a bit of deep water. For example in the cannabis industry, where you can say that no previously approved products are available. Now some pilot programmes are being made and new legislation is being prepared. When there are no previous approvals that you can lean on, it requires more focus on the interpretation of the legislation, and here AlfaNordic can contribute with both extensive experience, as well as consultants with extensive industry knowledge who have worked with cannabis as a new product. New products will always lead to the need for some additional legislation, and here it can be difficult to navigate without an experienced business partner.

Another area in which we believe we can deliver something very special is within GAP assessments. In the GAP analysis, we go and look for – it can be at a supplier or at the company itself – whether there are any gaps where necessary implementations haven't been made. GAP assessments are more comprehensive. It could for example be a company that goes from dietary supplements and will be producing pharmaceuticals or may want to enter the US market. Then new rules apply. Here we prepare a detailed GAP analysis, which is really good for the company, because they get the overall overview, and then they can help to prioritise which things should be done when etc.

This is something that is very important to AlfaNordic – solving tasks in a way that gives the customer a quick overview. Then we can help the customer to point out how and by whom the individual issues are best solved. So a GAP assessment – which is really just the complete deficiency list seen from a quality point of view – is a really good tool in many respects. Some companies may be able to make a sensible analysis themselves, but for most companies it would be a good idea to get some of these very heavily skilled consultants with 20 – 30 years of experience to join the project from the start.


Could you say something about which changes could be expected regarding what AlfaNordic will be offering within the quality area?

Gitte: We will be focusing more on pinprick operations where we are in there for example for a week and quickly deliver something that the customer can then go through and decide to 'use' or 'throw away'. The customer can immediately point out if there is something they would like to work more in depth with, etc.

Furthermore, as a customer you will experience greater recognition in what AlfaNordic delivers across the professional fields. We will focus more on our brand and the way it is reflected in our key deliveries, which we do in one way and with consistency. So far to some extent it's been a matter of personal CVs when we send someone out. We want to focus more on our culture and the common tools that express AlfaNordic and not the individual consultant, so that the customer recognises the quality of our work every single time and associates it with AlfaNordic's brand.

Facts

To a great extent, Gitte Lyngø has engaged in a wide range of QA tasks. Our QA/QC area delivers high–end services in compliance with Eudralex Vol. 4 (FDA210 & 211), CFR 820, and ISO 13485, incl. all guidelines."

Links

Contact Gitte Lyngø Nielsen

Latest news

Build GMP into your facility from the start with an owner consultant

In this article you can read about how an independent owner consultant can create value. Especially through assessment of the enterprise and through continuous monitoring of the progress. This is interesting if you are responsible for expanding a production, for new GMP facilities, or have an enterprise task to be solved. Especially if you do not have an established project organisation or project execution model.

Read more »

The consultancy A-consult lives on in a professionally strengthened AlfaNordic

After 35 years as an independent consultancy, A-consult opens a new chapter at the start of 2020, together with AlfaNordic: Since June 2018, when AlfaNordic bought A-consult, the two consultancy have gradually worked closer together by sharing knowledge, consultants and experience. From 1st January, 2020, they will also share their names as the collaboration continues under AlfaNordic A/S.

Read more »
en_GB
da_DK en_GB

Vi benytter os af cookies for at generere statistik samt optimere brugervenligheden og funktionaliteten. 
I vores cookiepolitik kan du finde mere information om vores brug af cookies og hvordan man sletter eller blokerer disse. 
Hvis du ikke aktivt foretager et valg, men fortsætter med dit besøg på vores hjemmeside, samtykker du til vores anvendelse af cookies.