I wrote recently about the skills you need to have a successful career in Validation, looking beyond simply having strong technical knowledge. I explored what differentiates a great Validation Lead from a good one (read here if you haven’t yet: What skills do you need to work in Validation?). Building on this, I have now had the privilege to gain additional insight from a QA Validation Manager who offers a fresh perspective on the topic. The individual in question would like to stay anonymous but is happy for me to share her sentiments, detailing what she feels are the 3 most important “soft skills” of a validation expert:
- Be a Real Team Player - validation is not a process anyone can do alone. There are a lot of different aspects to consider prior to even starting to plan any validation activity. The validation expert would know the regulatory requirements, but the system owner knows the system to be validated in depth including critical functionalities. The process developer has the knowledge about the critical parameters towards the products, hence it is crucial to involve him / her in the process as well. All the analytical testing is down to QC, so their expertise is inevitable to the project. Dependent on the use of the system, other colleagues from different department may need to be involved, such as Regulatory, Other engineering departments, Planning, QA (if validation is considered as a different department to QA), IT etc.
- Communicate - validation is a complex and lengthy project, so good communication is key. Not everybody is aware of all the details of the regulatory requirement, hence they might feel that what is required is ‘over the top’. Therefore, it is vital to explain to them in depth why certain elements of the validation are mandatory, and hopefully they will be on board with them. Always take your time to answer questions, this will be key to your success in the project.
- Listen - validation testing cannot be down to validation experts only. Still at many companies the validation experts are writing IQ/OQ/PQ protocols, frequently without any help. This is risky, as the validation expert is not a polyhistor (as much as we like to think we are), they do not know necessarily the best way to test the system. So listen to the experts! The system owner, the supplier, or even the operators, who operate similar systems on a daily basis. They usually know it better!
What do others think? If you enjoyed reading this please feel free to share and I will be interested to hear other ideas, including practical ways in which more junior Validation people can develop these skills.