VIJALKUMAR SHAH

Healthcare professional with a Master's degree in Pharmaceutical Technology, offering nine years of experience in Research, Production, Quality, and Regulatory roles within pharmaceutical, medical device, and Medical Cannabis industries. Skilled in optimizing Quality Management Systems and well-versed in Health Canada Food and Drug Act, NAPRA, Canadian Medical Devices Regulations (MDR/IVDR), US 21 CFR 820/211 (FDA), EU MDR, ISO 13485, and ISO 9001-2015. Experienced in navigating federal, state, and global regulatory requirements for pharmaceutical and medical device products. Proficient in database analysis, stakeholder and supplier management, electronic document management systems, and other aspects crucial for ensuring Quality and Regulatory compliant Operations.

Enhanced operational efficiency by 25% through the elimination of waste and rendered documentation more streamlined and supportive by employing SIPOC and Lean Six Sigma methodologies.

• Ability to comprehend and implement the Good Manufacturing Practices (GMP) regulations for Pharmaceuticals, Active Pharmaceutical Ingredients (APIs), Medical devices, In-Vitro Diagnostics.
• Fundamental understanding of Parenteral Sterile manufacturing and requirement for compounding preparation.
• Familiar with NAPRA/OCP regulatory compliance requirements for aseptic processing technique for hazardous and non-hazardous products.
• Played a pivotal role in providing comprehensive training through presentations on Quality compliance Procedures to the Internal stakeholders for various Quality management tools. E.g., GMP best practices, Customer return and Complaints and CAPAs.
• Experience using risk management methodologies such as Failure Mode and Effects Analysis (FMEA) and statistical analysis techniques, Such as Control Charts, to track/trend defects with digital solid and data analytical techniques, leveraging statistical tools like Minitab.
• Expertise in communicating with Internal and External customers, suppliers, and senior leadership, fostering a quality-focused culture.
• Experience using Quality management software like Scilife and Reliance ETQ, Enterprise software like SAP and SAGE, and project management tools to handle multiple projects and manage project plans, timelines, and deliverables.

• Earned Six Sigma White Belt certificate – Training and exam conducted by OraSure Technologies, USA.
• Earned a certificate- “Understanding of How medical Device Regulated in Canada” from Health Canada.
• Achieved a cGMP (Current Good manufacturing Certificate) from Canopy Growth Corporation.