Review batch documentation for commercial and clinical products and disposition product as per Standard Operating Procedures (SOPs)
Participate as QA Owner/QA Contact for Deviations, Corrective/Preventive Actions (CAPAs), Complaints, and Temperature Excursions (TEs)
Review Annual Product Reviews (APRs) for commercial products
Schedule, compile, review, and coordinate filing of Yearly Biologic Product Reports (YBPRs) for commercial products
Review Stability Summary Reports
Review Executed Batch Records
Draft SOPs, Protocols, Technical Reports, and memos in support of Quality activities
Run stability data reports, assess data, and issue memos in support of TEs for Amgen products
Complete Quality launch milestones
Develop and deliver GMP training
Represent IDQ Canada from internal/external audits and inspections
Represent IDQ Canada at cross-functional meetings for complaints, disposition, and launch
Represent IDQ Canada as a Subject Matter Expert (SME) during internal/external audits and inspections
Ensure compliance with Canadian Food and Drugs Act, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP) regulations
Liaise with other divisions within the Canadian office, U.S. Head Office, and other international affiliates to exchange information to meet objectives
Perform other quality tasks and projects as assigned by Manager
Qualifications
3+ years of Pharmaceutical Industry experience in a Quality Assurance role
Bachelor’s Degree in the Physical or Biological Sciences
Strong understanding of the Pharmaceutical and Biotechnology Industries
Understanding of Health Canada GMP Regulations, specifically as they relate to drug product importation
Understanding of Health Canada GDP Regulations
Prior product disposition experience
Prior experience reviewing executed batch records
Strong problem-solving skills, with sound judgment and the ability to make decisions independently while balancing business needs, quality and compliance risk
Strong organizational skills and an ability to manage multiple tasks and responsibilities in a dynamic work environment
Ability to follow assignments through to completion and meet timelines
Excellent communication and interpersonal skills
Strong attention to detail and critical-thinking
Prior experience using SAP and Quality Management System (QMS) applications
Advanced experience using Microsoft Office software (Word, Excel, PowerPoint)
