abu Hanif

WORK HISTORY

EDUCATION

ABOUT ABU HANIF

Quality professional with proven success in the Canadian pharmaceutical industry, currently working at PNP Pharmaceuticals, Burnaby, BC, as a QA Team Lead and Sanitation Supervisor. Lead and mentor the Quality Assurance team to ensure compliance with regulatory and company quality standards. Played a key role in leading the facility’s transition from Food/NHP to Drug manufacturing, aligning the Quality Management System (QMS) with Health Canada GMP requirements and preparing critical documentation such as Validation Master Plans, Cleaning Validation Master Plans, Equipment Risk Assessments, I/OQs, and Drug Manufacturing SOPs. Actively contributed to successful regulatory and third-party audits (Health Canada, NSF, BRCGS) with no major observations.Demonstrated expertise in supplier qualification, introducing vendor ranking and vulnerability assessments to enhance risk-based sourcing. Led or supported equipment and cleaning validations, and validated Excel-based tools in accordance with data integrity principles. Oversaw the development and continuous improvement of sanitation programs, validated new chemical agents, and implemented cost-saving strategies reducing sanitation chemical costs by 35%. Throughout my career, I have developed expertise in managing quality events, including Customer complaints, Out of Specification (OOS), deviations, CAPA, NCR, Qualify & approve suppliers including raw & packaging materials, and development and maintenance of an integrated Quality Management System (QMS). My focus on upholding data integrity and streamlining processes has enabled me to identify risks and implement effective solutions that support organizational goals.Bringing 8+ years of experience in global pharmaceutical operations with a consistent focus on product quality, patient safety, data integrity, and continuous improvement, I consistently identify risks, streamline processes, and implement sustainable quality solutions that support business objectives and regulatory compliance.