Professional Services (3) Lots for Quality Assurance (QA) Consultants for the CTMF

Description

To engage qualified consultants to provide Quality Assurance (QA) support during the operationalization of the Clinical Trial Material Facility (CTMF), in compliance with Health Canada, Food and Drug Administration (FDA), and European Medicines Agency (EMA) regulations, policies, and procedures. This request for proposals includes 3 lots as follows: 1. Lot 1 - Senior QA: one or two* resources providing QA oversight across GMP processes, validation, and operational readiness. 2. Lot 2 - Senior QA Data integrity/IT: two resources providing QA oversight for computerized systems, IT infrastructure, data integrity, and Inventory Management System (IMS)/e-QMS implementation. 3. Lot 3 - Junior QA: one or two* resources for Document and Training Systems, providing QA oversight over documentation and training management.