Gaurav Sirohia, nicknamed GK at the office, is a validation specialist working with the Quality Assurance team to ensure AAHI products manufactured for Phase 1 and 2 clinical trials meet the Food and Drug Administration's Good Manufacturing Practices (GMP) safety and quality standards and requirements before putting products into humans. GK is responsible for executing qualifications of equipment and manufacturing processes, product data analysis, and report writing. Motivated by our mission to create accessible health solutions for people in all areas of the world, GK is an important member of the AAHI team as we develop vaccine candidates through the product development pipeline and turn AAHI's scientific innovations into real health solutions.
We are here to assure that for whatever we manufacture, our processes are compliant and the quality is so good that no human has to suffer, but only make their life better.
What does a day at AAHI as a Validation Specialist entail?
My name is Gaurav Sirohia and people call me here GK, which are my initials Gaurav Kumar. I am a validation specialist here working in the QA department, which is Quality Assurance - a major part of GMP.
My day is mainly focused on two parts. The first part is executing qualifications, data analysis, and report writing, which is a main part of what a validation specialist should be doing. The other part is focused on compliance, which is not only my role, but everyone here should be compliant with what they are doing. I make sure that whatever equipment we have or processes we use are up to the industry standards and are in line with the regulatory guidance.
Why is Quality Assurance important?
Quality Assurance is important because if you inject something into a human you cannot take it back and it might have severe reactions if it is not done right.
We are here to assure that for whatever we manufacture, our process is compliant and the quality is so good that no human has to ever suffer, but only make their life better.
Why did you pursue a career at AAHI?
When I first joined, I was highly motivated with AAHI's vision to build a world where every person on the planet has the tool that can harness the immune system to live a healthy lifestyle free of illness and disease. That made me think that we are doing something that will actually impact a lot of lives.
What is your advice for people interested in becoming a Validation Specialist?
I would say start somewhere, that's the best advice. Most of the people think quality assurance is all about documentation, which, for the most part, is true. We require severe attention to documentation - but it is more than that. It is making sure that we are free of mistakes. Mistakes happen, we are all humans. But if QA is able to catch that before [a product] goes anywhere close to a human, then that's the best thing that can happen. And that's why I love QA. Just start somewhere.
What's your favorite thing about working at AAHI?
I have been here for almost two and a half months and although I am very new, I have seen that AAHI has a lot of social activities going on both onsite and offsite, which I thoroughly enjoy. And apart from that I always look forward to Fridays where we have a ping-pong game. I am a big fan of sports, so ping-pong is my thing.
I am more into cricket, which is very famous in India. I love playing cricket. I like indoor games like ping-pong, obviously, and some other board games. I love playing chess; so, if you are up for a match, bring it on.
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