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Lead Quality Assurance and IT Infrastructure Consultant

3 months ago


Ottawa, Ontario, Canada S.i. Systems Full time

Our esteemed Public Sector Client is seeking a Lead Quality Assurance and IT Infrastructure Consultant to assist in the execution and verification of IT infrastructure and data integrity for a new Clinical Trial Material Facility (CTMF). The ideal candidate will become part of a diverse project team, offering quality assurance expertise throughout the execution and verification stages of the initiative, ensuring adherence to relevant Health Canada, European, and FDA regulations. This position offers a full-time, hybrid work arrangement (with significant onsite presence in Montreal, QC).

Key Responsibilities:
  1. Evaluate and endorse validation documentation to ensure regulatory and GMP compliance.
  2. Confirm that documentation encompasses risk assessments, validation protocols, reports, deviations, gap analyses, and validation strategies.
  3. Assess and authorize Change Requests pertinent to the project for alignment with applicable regulations and CTMF protocols.
  4. Review and sanction quality assurance procedures, including those related to computerized systems, data integrity, backup and restoration SOPs, disaster recovery SOPs, and audit trail evaluations.
  5. Deliver quality assurance for validation and data integrity documentation associated with Trackwise digital enhancements and the deployment of an Inventory warehouse management cloud solution.
  6. Optionally, provide GMP compliance assistance and training to IT and automation teams.
Essential Qualifications:
  1. Over 10 years of experience in GMP regulation within the biopharma/pharmaceutical sector.
  2. A minimum of 5 years in a QA role.
  3. At least 5 years of experience in software/equipment validation or QA validation.
  4. Experience in at least one project involving cloud software validation or QA validation.
  5. Experience in at least one project related to QMS software validation (e.g., Trackwise, ZenQMS, Mastercontrol, ETQ).
Preferred Qualifications:
  1. Familiarity with data integrity protocols, including gap assessments, data criticality evaluations, audit trail reviews, and electronic record management.
  2. Strong proficiency in reviewing and approving quality assurance documentation.
  3. Exceptional communication and collaboration abilities.
  4. Capability to effectively engage with stakeholders and clients to ensure compliance and project success.