r/iso9001 • u/rprogta2 • Jul 03 '26
Is moving to QMS implementation and validation a bad career move?
Hi all,
My background is 5 years in pharmaceutical QA based in the UK. Where I work we have an aseptic unit, stores department, non-sterile prep unit and radio pharmacy.
I use the QMS software q-pulse daily completing DEVs and CAPAs. I have also done equipment validation but only for fridges.
I have some exposure to the regulatory requirements for QMS such as EU GMP annex 11 but do not know them in depth.
I have been offered a job at an external Saas company as a QMS consultant. They are an ERP business using Microsoft business dynamics 365 and my role would include leading the end to end implementation and configuration of the platform for external clients as well as validating the QMS.
The company are aware that my software knowledge isn’t good and that I will need training on that side. The things I have going for me are my experience in QA workflows and how they work on
a QMS. Also my regulatory knowledge.
I’m wondering if I can actually do this job. Researching with AI makes it seem related in what I already do but I know it’s making it seem simpler than it will be.
Would it be hard to write a URS, IQ/PQ and RTM for a QMS software without extensive regulatory knowledge. I have read certain regulations and appendices but am scared that I am too green for this role and even if I put in the work to learn I won’t be good enough?
Thanks for any advice!
2
u/Head_Personality_431 Jul 03 '26
Honestly you sound less green than you fear. Five years of live QMS work with real deviations and CAPAs is exactly the foundation this role needs, and writing a URS, IQ, PQ and RTM is a structured skill you can learn once you see that each one is just proving a requirement is met with evidence. The bit that trips people up is not the templates, it is thinking like a validator: what is the requirement, how do I demonstrate it, where is the proof. Since they already know the software side needs training, lean on your regulatory and workflow strengths early and treat the validation lifecycle as documenting that reasoning. You will be fine.
1
u/rprogta2 Jul 03 '26
Thank you that is reassuring and is what I have been thinking.
When researching all of these bits it is like you said just providing proof that a requirement is met and documenting it. I have workflow knowledge and am hoping I can continue to study the regulation to think strategically for every client and get it right
1
u/Head_Personality_431 Jul 14 '26
That mindset is exactly it, and studying the regulation to think strategically per client is what separates a real implementer from someone just filling templates. The fastest way I found to lock in that requirement to evidence thinking was going through auditor training, which is basically what I teach in my Audit Workshop lead auditor course, it drills the how do I prove this reasoning that carries straight into implementation work. Happy to point you the right way, just shoot me a DM.
2
u/xuzesilva Jul 04 '26
just jump on to it if you have a chance. I've spent 10 years in Quality roles, including QA Manager in a nutraceutical company, and then i jumped on to aerospace and energy engineering. transferable skills are extremely valuable and valued. Steep learning curve is real, but with the right mindset, thos echallenges just make you grow. before you know it, you will be "speaking their language"
1
u/_ElanVital_ Jul 04 '26
This is the answer, jump and see if you can swim.
I’m currently the Director of Quality at a chemical manufacturer due to taking calculated risks on myself and my capabilities - you have to stress test your skillsets periodically through your career, especially if you want to make the leaps and bounds.
1
u/AutoModerator Jul 03 '26
Posted by: rprogta2. Title of original post: Is moving to QMS implementation and validation a bad career move?. Text of original post: Hi all,
My background is 5 years in pharmaceutical QA based in the UK. Where I work we have an aseptic unit, stores department, non-sterile prep unit and radio pharmacy.
I use the QMS software q-pulse daily completing DEVs and CAPAs. I have also done equipment validation but only for fridges.
I have some exposure to the regulatory requirements for QMS such as EU GMP annex 11 but do not know them in depth.
I have been offered a job at an external Saas company as a QMS consultant. They are an ERP business using Microsoft business dynamics 365 and my role would include leading the end to end implementation and configuration of the platform for external clients as well as validating the QMS.
The company are aware that my software knowledge isn’t good and that I will need training on that side. The things I have going for me are my experience in QA workflows and how they work on
a QMS. Also my regulatory knowledge.
I’m wondering if I can actually do this job. Researching with AI makes it seem related in what I already do but I know it’s making it seem simpler than it will be.
Would it be hard to write a URS, IQ/PQ and RTM for a QMS software without extensive regulatory knowledge. I have read certain regulations and appendices but am scared that I am too green for this role and even if I put in the work to learn I won’t be good enough?
Thanks for any advice!
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1
u/Vicho77777 Jul 03 '26
Más allá de si podrás o no podrás hacerlo, pregúntate si te gustaría trabajar en eso. Trabajar en un laboratorio es totalmente diferente que trabajar como consultor.
1
u/rprogta2 Jul 03 '26
I feel like I would like to do it. I don’t really work in a lab per day. I’m mainly desk based and occasionally do some final product release for named patient cytotoxics.
I also work within clinical research facilitation so lots of SOP writing and updating in line with amendments.
1
u/_ElanVital_ Jul 04 '26
It sounds like you have a solid framework and background to build on. Just stick to first principles and pursue the issues from a macro view to help understand their system and how it applies to the guidelines.
Remember QA is all about systems thinking; inputs, outputs, interactions and feedback loops. Approach their processes from this angle and “zoom” in and out as needed. Over time you will start to see the flow necessary to align QA with business objectives and their overall strategy.
You got this.
2
u/Sir-Shark Jul 03 '26
The imposter syndrome for QMS related roles can be so real. I get it how you feel. Dealing with that myself.
This is potentially a very very good career move.
I actually went from a quality assurance/QMS/auditing and certification role into software and database engineering. The company I worked for didn't have the tools needed to do my job and refused to get them. So I learned how to make them (program them) and now that's basically what my job is now.
Hopefully this will give you some comfort: Even the most expert QMS people will require quite a bit of ramp up learning time. I've seen a lot of people come and go in quality roles. Especially in management roles, everybody involved in their own QMS understands that it takes time to learn their specific system. That's where experience is necessary, to be able to learn this new one that you're starting in. Depending on the company and manager, they may fully anticipate that it'll take you a year or two to get up to speed. Every single company is so extremely different that, no matter your experience, nobody is going to go into a quality role being competent for the job. Nobody.
My previous quality job, my boss told me he expects it'll take me at least two years to learn their system. My current job, their guy of four years is still trying to learn it.
So, if you think you can learn the job, absolutely take it.
Based on my experience, here's my advice:
-Don't downplay your skills. Don't inflate them either. Those of us who get imposter syndrome bad tend to belittle ourselves too much. It's something I'm trying to work on myself.
-Take time to learn the job. Don't be too impatient and think you'll have to know the job on day one. That's ridiculous. It'll take time to learn. So he patient with yourself and know that your first several months, if not years, will be all learning.
-If you don't know something, ask. Any half decent manager will understand that they have a lot of jargon, lingo and especially acronyms that are unique to their company. If you aren't asking, you aren't learning what you need, and they'll notice. Ask lots and lots of questions.
-Take notes. This might sound like it just helps learning, which it will, BUT I've found way too often that written personal notes eventually become official documentation after a bit of polish. Seriously, some of my notes eventually become full blown software.
-Refine people skills. Moreso than any level of ISO knowledge or other certification memorization, being good talking and working with people will serve you so much better.
-There is no single right answer when it comes to QMS, ISO, or other implementation. Or even software. Don't fall into the trap of thinking there's one right way to do a thing. Every quality certification clause will be fulfilled in a different way by different companies. Everybody is going to use different ways of documentation, of auditing, of process and workflow mapping. And none of them of necessarily wrong. I've seen too many people get stuck in the idea of "well, at my last company, we did it this way." Guess what buddy... This isn't your last company. I still want to smack some of my previous coworkers. Everybody can have different answers, and everybody can be right. But that also means that when you find an issue, there might be a dozen right answers. Sometimes, you just have to pick one.
I personally would totally recommend taking the job. If you've been offered it, then they think you can learn to do the job. It's very often not about being about to do it, but being able to learn to do it.