Hear from RSSL’s Qualified Person (QP) alumni about their experiences of our QP training programme.

Jo Harrison - QPJoanne Harrison

In the first in a series of interviews with RSSL’s QP alumni, we chat to Joanne Harrison - currently QP at MSD Animal Health - about her experience of our training programme.
  • What made you decide to become a QP?

    As a production manager, I regularly worked with QPs which gave me a unique insight into the day-to-day responsibilities of the role – and alongside the high profile and pressure, it was the job satisfaction and sense of achievement that most appealed to me. So when the opportunity came up within my organisation to move into the quality department, I immediately asked to be sponsored through the QP training programme. Fortunately, I was given the go-ahead.

  • Why did you choose to do your training with RSSL rather than
    another provider?

    The flexibility of the RSSL course was hugely important to me – not only in terms of the six-month module schedule, but also that fact that students are able to start at any point during the cycle rather than having to wait for an official course start date.

    The relatively short 2-3 days devoted to completing each module was also a motivating factor; it meant less time away from the office and home, as well as fewer expenses and accommodation costs.

  • How would you describe your training experience with RSSL?

    I found the RSSL team friendly and relaxed; they managed to balance detailed and challenging knowledge sharing, with thoughtful details such as making sure my favourite cake was available for lunch. The sessions themselves were interactive and informal which made for a positive learning environment. And I also met an interesting mix of people in diverse roles from companies of all different sizes, not just the big pharmaceutical giants, which was a welcome benefit.

  • What is the toughest part of your job?

    Having to say “no” to people. When you  are unable to release a batch, this decision will naturally have implications for the overall business, but my primary concern is product and patient safety – this has to come before everything.  So you do need a thick skin and it’s vital that you stand firmly behind decisions and remain consistent.

  • What is the most rewarding part of your job?

    Knowing that I am responsible for releasing products that will prevent or cure diseases. In my previous role I was releasing seasonal flu vaccine which can literally save lives, and my current work with large animal vaccines is just as rewarding because I know healthy livestock have such a huge positive economic impact.

  • What has been your biggest challenge?

    My VIVA – but don’t be put off! I found RSSL’s support invaluable in helping my preparation; I was able to attend full day 1 to 1 viva preparation sessions  where I could focus on my individual concerns and  I was able address those areas where I felt I was struggling.    

  • What advice would you give to anyone considering taking part in the
    RSSL QP training programme?

    First of all, don’t listen to those around you telling you there is only one provider; choose the QP programme that is right for you.  I qualified successfully first time and a lot quicker than some of my colleagues who went elsewhere.

    Secondly, choose your timing to join the course wisely. I found it advantageous to go into the QP programme with significant experience already behind me, which enabled me to put what I learnt into context and get more out of it.

    And on a practical note, write everything down in your working day that is relevant to a QP role.  This will prove incredibly valuable when you come to complete your VIVA application form as you will have a record of your achievements.

Nina Dosanjh - QPNina Dosanjh

In the next in our series of interviews with RSSL’s QP alumni, we talk to Nina Dosanjh - acting head of quality at Perrigo - as she looks ahead to her VIVA examination.

  • What made you decide to become a QP?

    Having worked often worked alongside QPs in technical/lab-based roles, I wanted to better understand their decision-making process; particularly as I didn’t always agree. So I saw it as an opportunity to deepen my knowledge and give me this broader perspective, but also to influence those outside the quality arena.

  • Why did you choose to do your training with RSSL rather than
    another provider?

    In a nutshell – costs. As one of three employees starting QP training at around the same time, there simply wasn’t enough in the budget to send me on the course the other two trainee QPs had already signed up for.

    On reflection, however, the fact that RSSL covers each module in just two or three days worked much better for me; not only in terms of a less intensive training style, but also justifying and managing my time away from the office. Interestingly, two trainees have since gone on to join the RSSL QP training course.

  • As you look ahead to your VIVA, how are you preparing?

    My mock VIVA is currently scheduled for July, so since completing the modules last year I have taken advantage of RSSL’s webtorials, which are offered to students as a way of to reinforce understanding and further develop skills. I have found the different scenarios covered in these online programmes extremely useful.

    The support offered by the RSSL training team is also reassuring. They get in-touch every so often to make sure everything is going well, and I know I can always contact them if I’m struggling or have questions as they are very approachable.

  • How would you describe your training experience with RSSL so far?

    On the whole, I would say it has been really good. In fact, I was quite sad to finish the last module as I’ve enjoyed the learning process. RSSL creates a structured learning environment which is highly informative, without being too heavy going. And I’m already seeing the benefits of the course in my day-to-day work.

    Getting out of the office and meeting people from different organisations has also been fantastic; I’m in-touch with many of them on a regular basis and they are now an important part of my network.

    On a more practical note, when I needed to reschedule some of the modules - often at the last minute, due to work commitments - RSSL was very flexible and there was never any question of a financial penalty; I was simply allowed to re-book at a later date.

  • What have you found to be the most valuable aspect of RSSL’s training course?

    For me, it’s the fact that RSSL tutors provide a solid foundation but don’t give you everything you need; there is an expectation of a certain level of independent learning.  It’s a teaching style that may not suit everyone but I found it an extremely effective way of consolidating what I had learnt on the course. It means students are pointed in the right direction, but then it’s up to the individual to seek out the relevant information. 

  • What advice would you give to anyone considering taking part in the RSSL QP training programme?

    Thoroughly research QP training before you commit to a course. You will also be working full time, so being able to manage the pressures of your job responsibilities at the same time is essential.

    Once you start the course, don’t forget to spend time going through your notes at the end of every module. Make sure they make sense and edit the content while the information is still fresh in your mind – you’ll be very glad you did when it comes to revision.

    Plan ahead for your VIVA application form. It’s difficult and time consuming, but you can ease the process by completing the relevant sections as you go along, rather than leaving it to the end of the course.

    Build a network for support. I set up two study groups - one made up of external contacts I met at RSSL, the other internal QP and QA professionals – and found that people are generally happy to help and be involved.

    Be organised, don’t panic and don’t be pressurised into putting in for your VIVA too soon – especially if you’re not ready.  

Achille Tzoris - QPAchilles Tzoris

Continuing our series of interviews with RSSL’s QP alumni, we catch up with Achilles Tzoris - head of quality and compliance at Animax.

  • What made you decide to become a QP?

    Coming from a family with a medical background, I have always been involved in discussions about medicines, diseases, cures and formulations. This has given me a strong belief in the quality and safety of medicines, which has been a guiding principle throughout my long career in human and veterinary health pharmaceuticals.  

    So as soon as I realised the scope of the QP role, I saw it as an interesting way to broaden my knowledge and fulfil my childhood dream of exploring every available opportunity for a chemist in the pharmaceutical sector.

  • Why did you choose to do your training with RSSL rather than
    another provider?

    RSSL was recommended to me by industry professionals, but I also had the chance to take part in a preliminary training session run by the organisation several years ago when I was impressed by the presentation of the training package, the tutors at that time and the cost to benefit ratio.  

    In addition, I believe that the QP modules offered by RSSL are better tailored to working individuals.  They may be more concise on content than similar modules offered elsewhere, but they are more suited to a busy and experienced QP candidate such as myself.

  • What stage have you reached in your QP training?

    It took me little more than a year to complete all 12 modules and I am planning to take my VIVA later this year.

    The main issue for me is finding the time to prepare while also being extremely busy at work. As a result, I’ve had to put back my VIVA but certainly want to take it before Brexit which could potentially complicate the situation for me.

  • How would you describe your training experience with RSSL so far?

    Absolutely enjoyable! I miss it and if I could justify the expense, would happily do the course again just for fun of – and possibly to fill in any gaps I’m not aware of.

    The level of tutors was extremely high; their knowledge, experience, delivery of the subjects, innovative approach and general approach made it a joy to attend.

  • What have you found to be the most valuable aspect of RSSL’s training course?

    The confidence that an experienced and knowledgeable tutor can pass on to the trainee - and the ability to apply it. 

    When I got back to my day job, I realised that I was using what I had learned from the training course automatically; almost subconsciously. Of course, it doesn’t happen magically. You do have to work hard, engage with what’s on offer and expand on it in your own personal time.

Azeem Shan - QPAzeem Shan

Next in our series of interviews with RSSL’s QP alumni, we speak to Azeem Shan – a QP and Quality Assurance (QA) Consultant.

  • Would you say that your background is typical for a QP

    My route to QP qualification began with a BSc (Hons) degree in Industrial Pharmaceutical Science, followed by a second in Pharmacy (MPharm) at Liverpool John Moores University. Early on, I had a strong interest in analytical chemistry, and volunteered during my academic vacations to perform research in the laboratory, which helped me gain in-depth knowledge on techniques utilized in the pharmaceutical industry. Post university, I worked as a registered community pharmacist and was approached to take on a Responsible Person (RP) role within the company. I undertook a dual role of becoming a RP for wholesale activities and as a community pharmacist; this allowed me to manage the Quality Management System (QMS) and deal with the MHRA for Good Distribution Practice (GDP) inspections. This rekindled my interest in the pharmaceutical industry, and in how inspectors apply their technical and regulatory knowledge to ensure compliance.

    Becoming a QP was a natural step for me. My pharmacist experience and strong foundation in the industry helped me to connect with the QP modules and diligently assume the responsibilities that come with the QP role.

  • Did you always want to be a QP?

    My first exposure to QPs took place at university through a lecture on Pharmaceutical Development, by a pharmaceutical consultant. Although the speaker presented QPs in a rather negative light; describing the position as isolated, monotonous and with the sole responsibility for patient safety - it got my attention! In fact, it motivated me to look into the role further and, even though I knew it wasn’t for me at that time, the possibility stayed with me.

    Whilst in the pharmaceutical industry I was fortunate to have inspiring QPs as colleagues who served as motivation to undertake the challenge and pursue this role. Hindsight is 20/20, so when I look back, becoming a QP was a natural step - particularly given my background and my relish for a challenge.

  • So tell me more about your industry experience?

    I have about a decade of experience with the manufacture, packaging, testing and more recently, the certification of human and veterinary medicines, both as clinical trial materials and as commercial medicinal products. I have experience in a wide range of dosage forms and also medical devices.

    Throughout my time in the industry, I have witnessed the constantly evolving regulations and industry standards, and have first-hand experience with regulatory inspections by various international regulatory authorities as well as client GMP audits. I have been involved with facility expansions, new product introductions, regulatory and compliance assessments, remediation work, technical and regulatory issues, training and also auditing facilities to EU GMP standards. Given my pharmacist qualification, I also have extensive experience working with unlicensed specials, adverse drug reaction reporting and pharmacovigilance.

  • Why did you choose to do your training with RSSL rather than another provider?

    Cost and flexibility were definitely the main drivers. The modules were well-paced throughout the year, so I could pick and choose. Most importantly, each module was less than three days, which I found extremely helpful in terms of balancing work and study commitments. This format also allowed time to do independent research, understand different approaches and form my own opinions on key topics.

  • How would you describe your training experience with RSSL?

    It’s a very welcoming environment, with RSSL support staff and tutors who are engaging and supportive at all times, irrespective of whether it’s your first or last module.

    There are also plenty of opportunities to meet people from different backgrounds within the industry, which leads to gaining new perspectives and building a valuable network.

  • What have you found to be the most valuable aspect of RSSL’s training course?

    Having time to sit down with Alex, one of RSSL’s core tutors, to run through a mock viva and review my QP application form. Although I had been working with my sponsor on a daily basis, having Alex’s input gave me a fresh perspective which I found beneficial. My RSSL’s tutor had a solid benchmark from our first meeting, and knew my areas of strength and weakness, and where I needed to develop. She also knew what the QP panel would be looking for, and could offer relevant guidance and advice.

  • Is the QP role what you expected?

    Yes - and more! Being a QP allows me to play an integral role in the drug development and lifecycle process. It allows me to weave together my pharmacist and industry experience to ultimately support patient safety, which I have experienced first-hand working in the community and hospital pharmacy environment. Knowing that I am directly making a difference in people’s lives make it all worthwhile; this is by far the most fulfilling part of working as a QP.

  • What advice would you give to anyone considering taking part in the RSSL QP training programme?

    If you fail to prepare, you are preparing to fail. During your QP training programme, you have to be organised, disciplined and put real effort into the relationship with your QP sponsor. Be prepared to take constructive criticism and don’t become complacent, afterall revising a topic is one thing, but to have an in-depth discussion with an expert is another.

    Post QP modules (prior to the QP viva), I would recommend spending as much time as possible with other QPs, trainee QPs and subject matter experts as it’s important to get out of your comfort zone. Each QP training module are complementary to others, where the core modules are linked to all of the modules; ensure you invest the time to thoroughly understand a topic from different perspectives.

    You can’t possibly know everything and there are people around you who can help. It’s about understanding your weaknesses, so that you can take action to become more knowledgeable. But above all, don’t forget to enjoy the ride!

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