Michael Darias

Michael Darias has a diverse and extensive work experience in the field of quality assurance and regulatory compliance. Michael is currently serving as a Senior Manager QA & Regulatory at Sunstar Americas, Inc., where they are responsible for developing, leading, and executing Canadian quality assurance and regulatory requirements. Michael manages all product testing resources and ensures compliance with corporate policies and quality management system procedures.

Prior to this, Michael worked as a QA/QC Manager at Germiphene, where they managed the Quality Control, Microbiology lab, and quality assurance team. Michael recruited and developed a high-talent staff and motivated team members to perform to their full potential.

Before joining Germiphene, Michael worked at Contract Pharmaceuticals Limited, initially as a Product Quality Specialist level 2 - Complaint Investigation. In this role, they received and acknowledged Product Quality Complaints, conducted investigations following regulatory guidelines, and suggested proper CAPAs. Michael also had a role as a Production Quality Inspector-Quality Assurance, where they ensured compliance with SOPs and GMPs.

Michael also gained valuable experience at Apotex Inc., serving as a Project Leader, Global Field & Mkt Resp. Michael was responsible for managing escalations, field actions, and regulatory communications, coordinating investigations and recall activities, and ensuring compliance with regulatory requirements.

Additionally, Michael worked at GSK as part of the Operational Quality Assurance team, ensuring regulatory and quality requirements were met for imported products to the Canadian market. Michael investigated quality incidents, prepared presentations to health authorities, and inspected batch documents.

Earlier in their career, Michael worked at Alfacure Pharmaceutical as a QC Manager and Compliance Manager, overseeing quality control departments. Michael also served as a GMP Auditor and Trainer, as well as a QC Section Head at Minapharm Pharmaceuticals.

Overall, Michael Darias has a strong background in quality assurance, regulatory compliance, and management, with experience in various roles and industries throughout their career.

Michael Darias has a diverse educational background with a focus on business administration, training, auditing, quality management, computer sciences, and pharmaceutical sciences. Their education history is as follows:

- From 2013 to 2015, Michael pursued a Master of Business Administration (M.B.A.) degree in Business Administration and Management, General from Paris ESLSCA Business School.

- In 2013, they also attended the University of Cambridge and obtained a Certified International Diploma for Trainers and Teachers, with a focus on adult education.

- During 2012 to 2013, Michael studied at EQE (Experts and Quality Engineers) and earned an IRCA Certified Lead Auditor Certificate (ISO 9001:2008) in the field of auditing.

- In 2010 to 2011, they completed a Total Quality Management Diploma at The American University in Cairo, specializing in quality management.

- In 2009 to 2010, Michael received the International Computer Driving License (ICDL) from UNISCO, with a focus on computer and information sciences and support services.

- In 2011, they attended Alexander International for the Training of Trainer (TOT), emphasizing adult and continuing education and teaching.

- In 2008, Michael obtained the International Permedic certification from the Egyptian Red Crescent, focusing on first aid and triage.

- Lastly, from 1996 to 2001, they attended Cairo University, earning a Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, and Administration.

In addition to their academic achievements, Michael has obtained the ASQ Certified Quality Auditor certification from ASQ - World Headquarters in December 2022. Michael also holds additional certifications: CIDTT from the University of Cambridge, an MBA from ESLSCA France, and TQM from The American University in Cairo, although the specific dates of obtaining these certifications are not provided.