Megha Vivek
Quality Operations Specialist @Evonik
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WORK HISTORY
Quality Operations Specialist @Evonik
Burnaby, BC, CA
EDUCATION
PES University
Bachelor of Engineering (B.E.)
Sri Bhagawan Mahaveer Jain College
Pre university
Dalhousie University
Masters in Biological Engineering
ABOUT MEGHA VIVEK
I apply my engineering background and skills in bioscience and renewable energy to ensure the highest standards of quality and compliance in the production of biopharmaceutical products. I have over four years of experience in quality assurance, deviation management, and document control in the pharmaceutical and healthcare industries. I have successfully participated in an EMA audit that resulted in a GMP certification for the organization, and I lead the production department in overseeing all production-related activities. I also review and create QMS documents, GMP documents, and SOPs, and perform document control tasks. Additionally, I have authored multiple deviations, investigations, and CAPAs for various manufacturing processes, and supported batch release while complying with quality requirements. I am passionate about applying my knowledge and skills in bioscience and renewable energy to contribute to the innovation and sustainability of the biopharmaceutical sector.
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