Sherin Joseph

Background

About Sherin Joseph

GMP Auditor at Medsafe (New Zealand Ministry of Health)| ASQ Certified Quality Auditor | 27 Years of Pharmaceutical Quality & Compliance Leadership About: As a GMP Auditor at Medsafe, Ministry of Health, NZ, I leverage 27 years of extensive experience in pharmaceutical quality assurance, technical compliance, and quality control. Previously, I spent 23 years as a Quality Manager/Compliance Manager at Riyadh Pharma, where I was instrumental in establishing and leading all quality systems to ensure full compliance with European GMP from the factory's commissioning. I am an ASQ Certified Quality Auditor with over 15 years as a Lead Auditor, having conducted more than 100 comprehensive audits across India, China, Europe, the Middle East, Singapore, New Zealand, Australia, and the USA. My auditing scope spans APIs, excipients, packaging materials, medical devices, drug products, analytical labs, pharmaceutical distributors, and more. I possess in-depth knowledge of global regulatory requirements, including Medsafe, MHRA, Saudi FDA, GCC, US, European, and TGA regulations, and have successfully managed over 50 regulatory audits from various agencies. My background includes strong capabilities in pharmaceutical plant operations, quality improvements, production, engineering, warehouse management, planning, and formulation development. I've also led critical projects such as the implementation of Electronic Quality Management Systems (eQMS), Electronic Batch Records (EBR), and serialization (Track & Trace). Proficient in aseptic operations and data integrity, I'm dedicated to upholding the highest standards of GMP compliance and fostering quality excellence through comprehensive training and staff development.