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