As a specialism, Validation attracted me as a Recruiter when I supported an SME company to find a Validation Technician for them. So then, I researched the topic and started to talk to professionals within the pharmaceutical industry to gain a deeper understanding of their profession. It is such a broad and varied professionalism and in my opinion, it requires a range of very specific skills of a person to thrive in a role related to validation.
So, what are these skills? And, just as importantly, what differentiates a great Validation Lead from a typical one? What are the softer skills that really sets the best people apart from the rest?
I asked Rafael Skrzyniarz (Head of Global IT Validation Services at Takeda Pharmaceuticals, who has 19 years’ experience in the world of pharmaceuticals) to share his opinion with me on what skills you need to work in validation. I like how he described it from the perspective of a validation lead and put his summary into 3 categories:
Typical Validation Lead: Besides the obvious/typical soft and hard skills, including understanding of the regulatory requirements:
- Good documentation skills - The documentation needs to be able to stand on its own even after a couple of years.
- Methodology oriented and ease of adopting different/new ways to achieve the same end goal - Even if the overall validation steps are the same, different companies and validations may require different methodology
- High integrity - ability to create trust and confidence, is key to a successful risk based validation
Good Validation Lead: Besides the above,
- Good PM skills - getting a close alignment of the validation activities with the overall project objectives, planning and budget is key for a successful and timely execution
- Process and activity focused. - Validation is not a set of documents that must be produced. It’s the steps and activities that produce the value.
- Ability to explain, train and coach the project team, of the purpose and value of the steps and activities in a tangible way - Validation is not only a Validation (Lead/team) exercise. Project and system quality comes from all involved stakeholders, and cannot be documented/tested in. Quality needs to be build/trained into the SW, processes and people using it.
Great Validation Lead: Besides all above,
- Ability to understand the business need/value/regulatory and quality risk, and focus the validation of the high risk/high value adding areas, while maintaining sufficient level for the rest of the software. - Given time/budget, 100% validation is not achievable, nor realistic
- SW Domain understanding or ability to quickly understand new SW concepts and be able to successfully apply appropriate SDLC methodology (Validation strategy/process/activities). To ensure quality and minimize/eliminate the risk to patient and product. - With current/new SW "technologies" like bit block, AI and IoT... A solid validation lead uses the validation methodology to ensure a quality outcome, with the documentation to prove it. The outcome should always focus on risk to patient, product and then business. I.E. focus to ensure Quality and compliance with regs. as an outcome, rather than to satisfy regulations as primary. Regarding personality, ability to lead by influence, high integrity and perseverance, are almost a must, depending on the maturity/culture of the company.
Overall it requires someone who can be versatile, has a methodical mind, analytical thinking, attention to detail, good documentation skills, the ability to find creative solutions to complex problems and strong maths and IT skills. But the best Validation professionals are the ones who see the bigger picture, and who understand the broader context of what they are trying to achieve.
What do others think? If you enjoyed reading this please feel free to share, and I will be interested to hear other ideas.