Meet Niral Shah, the next featured member of our deeply passionate team here at AgPlus. As a Quality Manager, Niral talks in more depth about her role within the company and the exciting year ahead.
A BIT ABOUT niral
Niral is a confident and highly organized Quality professional with experience in QC, QA, and QE. She completed her graduation in B.tech Biotechnology from a university in India and post-graduation in Environmental Biotechnology from the University of Manchester. Utilizing her in-depth knowledge and experience in Pharmaceutical, Medical Devices, and IVD Industry, she has come to embrace the need for standards and regulations. With an exemplary passion for problem-solving, and organization skills, Niral seeks to hone her knowledge of lean six sigma and further develop her leadership skills.
When Niral is not working, you will find her travelling, painting or enjoying simple pleasures of life like playing board/card games with her family and friends.
As a quality manager, I am the first point of contact for all quality and regulatory quires, I support all departments to comply with ISO 13485 standards. My job also involves establishing and maintaining an effective Quality Management System to ensure that the product or service that AgPlus provides is fit for purpose, consistent and meets both external and internal requirements. This includes legal compliance and customer expectations.
STARTING WITH AG+
I was brought in 2 years go to establish a QMS that is compliant with ISO 13485 and obtain certified status. With a degree in biotechnology and understanding of the immunochemistry combined with my experience in Quality control, Quality Assurance, and Quality Engineering I have developed my understanding and importance of Quality and Regulatory requirements which was essential for my role at AgPlus.
BEST PART OF THE JOB
I enjoy working at AgPlus, and as every day is a new challenge with new things to learn. Working in Quality can be monotonous and repetitive but not at AgPlus. Being in a small team I get to do everything, from completing documentation or gap analysis to making improvements in the processes for better efficiency. Best part of my job is working closely with different departments and all my colleagues from various backgrounds, I have been learning new things every day and enhancing my skills.
THE YEAR AHEAD
The coming year has a lot of deadlines and achievements that need to be accomplished. Cartridge and reader advancement for internal development and chemistry enhancement for external development. One of the major milestones for the next year is to incorporate manufacturing and validate the processes to update the ISO 13485 scope for certification. I am also looking forward to implementing ISO 18001 and 14001 for future certifications.
If you'd like to get in touch with Niral directly, please call +44 (0) 1234867103 or click here to email.