QA (Quality Assurance) Engineer Mairane Costa details one of her first experiences at Life Sciences customer site, what was involved, and what she learned from the process.
What was your job there?
I was QA (Quality Assurance) Engineer, reviewing technical documentation and authoring documentation for small scale equipment. It was a 3 month placement and a very enjoyable challenge as I hadn’t worked on small scale equipment before even though I had been trained to work on all aspects of the validation lifecycle. It was a great experience!
What do you enjoy most about your job?
We had a great team; everyone was supportive of one other. I have a great opportunity to learn a bit of everything. Working on-site gives the opportunity to closely follow and understand the process in a live environment.
What was the most difficult phase?
The first two weeks. The environment was a new experience for me, but as I already said, I had a great opportunity to work with a wonderful and experienced team. Also, I was well trained by the Odyssey VC Team.
Do you recommend this experience to other engineers?
For sure. We learn much more when we work on-site. It is an opportunity to work with different professionals and be exposed to different experiences.
What is the purpose of going on-site?
The purpose is to have access to the necessary documentation. Also the project had very tight timelines which meant that site presence was a must.
Is your job checking and controlling the procedure in place?
Yes. My job was to verify and review technical documentation to ensure it meets company and regulatory standards before moving to the next step or closing it.
What can happen if you find something that is not correct?
Because I was working on-site, I was close to the person who was involved in the technical documentation. If I found an issue, I could personally ask this person to address my comments and make the appropriate corrections according to the standards and given the tight timeframe this ensured that the review cycle was very efficient.
So, you should be a really precise person?
I am a precise person. I am a very organised person; I have a daily routine; it helps me to feel more in control of my time. I need to be precise, to prioritize what is important, and classify an order. Also, I need to pay attention to all the details. Life sometimes gets out of our plans; I need to be ready for changes prior to it happening.
Was that your first experience on-site?
I was a Physiotherapist before; it helped me grow so much professionally. I learned a lot from my time as a Physiotherapist and I could develop different skills. Also, during my time as a student, I worked for a multinational corporation in the petroleum industry. Basically, I was responsible for processing receipts and shipments of equipment to support the IT team.
Even though I was doing well, one day I decided to follow my heart and try something different. Then I was back to college in Ireland doing my second degree. I learned all about the lifecycle of medical devices. One of my subjects was about regulatory standards and quality procedures; since then I felt that it was what I wanted to do, no doubt about it. This year I completed my postgraduate in Quality Management and Lean Systems. I am currently a Black Belt in Lean Systems.
Why did you choose this path?
I liked it and I am very happy that I have chosen the right path for my skills.
What skills have you gained?
The importance of teamwork. You always have something to teach and share, and it’s great interacting with others who have different experiences. Life is learning and the sharing of experiences.
Do you have any advice for people going on-site for the first time?
Be energic and enthusiastic. Do not be afraid to ask questions.
Would you like to work on another project?
Yes, I am looking forward to working on my next project. I am hungry for knowledge. I am gaining a lot of experience, and I want to keep building that up.