One reader, early in their trainee QP journey, reached out to ask what activities they could do to help build out their application.

I would respectfully suggest this is the wrong question.   The goal of your period as a trainee is to make you a QP at the end – the process of gaining QP status is in effect a secondary outcome.  You need to be able to be the QP from the moment you finish that application – because that is you saying, “I’m ready.”

If you get involved in the right activities- you will gain the experience you need - then you need to write it down.

So how do you start to do things that turn you into the QP you want to be?    Here are a few potential things to get stuck into to try and flesh out your experience. All of these should be discussed with your sponsor and/or your line manager.

1)      Go where the system needs fixing. 

I have yet to find any company or person that says their operation is without flaw.  Every single site with a manufacturing licence will have issues that need fixed.  Potential work will be generated either by change imposed from outside (See the recent Annex 1 revision for a work generation activity) or by a desire for continuous improvement. Rarely does the QMS and the processes it supports sit still.  

So, find where change needs to be done and do it yourself.  I don’t mean review and approve changes alone but get hands on with changing your QMS or even a production or QC process itself. 

It’s far more educational to try and change the system than merely watch it change and nod along.

As an example – how would you implement a change to increase a batch lot by 100%?  How would you make one of your production processes continuous?  How would you improve your raw material receipt system? It will take work but its invaluable learning.

2)      Build an expertise in part of your business.

You should understand that you need to stand out and be known as a source of reference for at least one area – be it stability review, HPLC analysis, environmental monitoring or production of a particular API etc.

If you're just another heifer in the herd of quality people, nobody's going to notice you and, more importantly no one will come to you with problems. QPs get hit with problems/issues/please help fix this constantly, so you need to get familiar with the feeling.  It will also involve you in cross functional problems or projects that will build out your documentable experience.

3)      Review and Propose

It takes a village of people to run a manufacturing site, big or small.  No one can run a site with an MIA single handed.  This leads to very well-trodden roles within the industry and a standard pattern of work.  One of these you will be familiar with is QA approval of everything.  Trend reports, process performance reports, maintenance reports, OOS/OOT and validation documentation.   Please read, nod and sign here….

Its important to not just review and correct, take the review process and use it to understand the system and then propose how things could be improved.  A major soft skill you will need is influencing people to make positive change and using review processes to help you start these conversations is a good way to gain some momentum.

4)      Dry run a certification.

Take a batch that your sponsor QP has certified and (with giving them a heads up beforehand) see if you could comply with all the legal duties within Annex 16 without delegating these to anyone else such as a batch review team – could you lay your hand on every piece of information you need to satisfy yourself the batch is compliant to the requirements.  DO it for a product you know and move on to products unfamiliar to you.

Each of these suggestions has the added benefit of helping you build up strong connections with the network of people who operate at your site.  It also has the benefit of making you familiar with parts of the business you may not have been exposed to before and build some of the soft skills you will rely on.

These are only a couple of things to try.  Make use of your sponsor when proposing what to get stuck into.