Choosing curiosity

Your approach as a trainee QP will always be shaped by the business structure you sit within. Which will dictate how far you sit from the front lines.

Personally I think as a trainee you need to find and jump headlong into the “thick of it” where QA meets the operational realities of a business, to learn what will work and what won’t.

This in turn is based on a personal belief that the greatest source of learning you have access to is using your own lived experience of your processes, problems and quality systems to learn the broader underlying foundation and additional knowledge you need to have.

This both gives you a structure to hang your learning on but also encourages you to prepare to certify your site by learning the business “top to bottom”.

It sets a bar that is often daunting - but you need to know the processes you quality assure as well as the majority of people executing them on the front line.

While that sounds almost ridiculous when taken as an isolated statement - the truth is if you want to be known as a QP you are trying be a person that is both legally and institutionally viewed as someone who understands both the foundations and the intricacies of this pharmaceutical lark better than most.

If you don’t understand the operational reality of the processes you are taking responsibility for you don’t understand how easy or hard they are to comply with and you will not understand the potential for non compliance that will undermine your quality system.

Approaching with curiosity, daily, and being open to discovering issues within pharmaceutical quality assurance allows us, as QA professionals, to uncover the underlying issues individuals are addressing, encouraging transparent communication to quality rather than defensiveness.

Consistently employing this approach enables you to cultivate a reputation as a problem solver within the quality assurance unit as opposed to a compliance dictator. While it will at times cause you to ask “why me?” a queue of individuals seeking advice at your door will be a sign of development as your expertise becomes sought after.

This positions you advantageously. Team members actively seek your input to prevent risky process adaptations (proactive risk management). Simultaneously, you maintain a broader perspective on change management in practice, even those beyond your immediate influence.

Therefore at the point you qualify and have to rely on the PQS and the people within it - the organisational relationships exist to let you certify.

It will also shape your reactive risk management. Your disposition decisions and deviation risk assessments will be driven by the risks identified on the operational front lines and the potential worst-case outcomes if these risks were realised.

It’s not an approach that I am always able to follow. It’s hard to constantly be open minded to every issue that’s thrown your way but it is an approach that helped me learn the ropes.

So the core of this blog post is, read less blogs, fix more problems.