Seeking a challenging position in Quality Assurance within the chemical and pharmaceutical industry; leveraging over 10 years of experience in ensuring regulatory compliance, optimizing quality management systems, and driving operational excellence.
• Enhanced customer satisfaction by investigating non-conformances and initiating Corrective Action Reports (CARs), warranting precision, timely resolution, and adherence to quality standards
• Analyzed and reported trends and metrics related to Quality Management Systems to drive opportunities for improvement
• Conducted ISO 9001:2015 and ISO14001:2008 internal audits and facilitated external audits to verify compliance with regulatory requirements
• Executed HACCP audits ensuring food safety and compliance with regulatory standards
• Liaised with internal departments, management and external stakeholders including customers, suppliers, contractors, and carriers to gather and disseminate critical information across sites
• Governed change control activities and communicated effectively with customers to ensure seamless transitions
• Performed risk assessments on potential new projects, helping management make informed decisions about resource allocation and project priorities
• Prepared and organized management review meetings to evaluate performance and drive strategic decisions
• Drafted and collaborated on deviation reports, revision of controlled documents, and SOPs ensuring precision and alignment with regulatory and quality standard requirements
• Responded promptly to customer and supplier inquiries regarding quality information to maintain strong relationships
• Facilitated training sessions on Quality Management System principles to enhance staff knowledge
• Authorized the release of imported pharmaceutical drug(API) consignments in compliance with government regulatory bodies such as Health Canada
• Implemented quarantine and process deviation protocols and oversaw material disposition following a thorough investigation
• Maintained updated knowledge and implementation of industry best practices such as GMP, GLP, OHSA, environmental sustainability, risk management, and continuous improvement processes.
Proven ability to work well independently and within team with minimal supervision
Excellent communication and organizational skills
Strong root-cause analysis (RCA) capabilities
Proficient in all of MS Office: Excel, Adobe, Outlook
Trained in Occupational Health & Safety, WHMIS, GMP, HACCP and QMS
Competent in risk assessment and change management
Robust analytical chemistry and testing skills
Knowledgeable in regulatory compliance and industry-specific requirements
Mastered documentation and reporting skills
Proficient in time management and task prioritization
Adaptability to work in a fast-paced stressful environment
Aptitude in multitasking and managing multiple projects simultaneously
Certificated ISO 9001:2015 Lead Auditor | SAI GLOBAL
Certified ISO 9001:2015 Internal Auditor| SAI GLOBAL
Certificated ISO 14001: 2008 Internal Auditor | SAI GLOBAL
BRCGS-Food Safety Internal Auditor| Lumar Food Safety Services