Tendarix.ca
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.
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