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Senior QA and IT Infrastructure Specialist to support the implementation and validation of IT i[]
3 months ago
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Job DescriptionOur Public Sector Client requires a Senior QA and IT Infrastructure Specialist to support the implementation and validation of IT infrastructure and data integrity for a new Clinical Trial Material Facility (CTMF). The successful candidate will join a multidisciplinary project team, providing quality assurance support during the implementation and validation phases of the project, ensuring compliance with applicable Health Canada, European, and FDA regulations.
Work Model: Full time, hybrid work model (up to 70% onsite in Montreal, QC)
Responsibilities include:- Review and approve validation documentation for regulatory and GMP compliance purposes.
- Ensure the documentation includes risk assessments, validation protocols, reports, deviations, gap assessments, and validation plans.
- Review and approve Change Requests related to the project for compliance with applicable regulations and CTMF procedures.
- Review and approve quality assurance procedures, including computerized systems procedures, data integrity, backup and restore SOPs, disaster recovery SOPs, and audit trail reviews.
- Provide quality assurance for validation and data integrity documentation related to Trackwise digital upgrades and implementation of an Inventory warehouse management cloud system.
- Optionally, provide GMP compliance support and training to IT and automation teams.
- 10+ years of experience in GMP regulation in the biopharma/pharmaceutical industry.
- 5+ years of experience as QA.
- 5+ years of experience in software/equipment validation or QA validation.
- Experience in at least one project in cloud software validation or QA validation.
- Experience in at least one project in QMS software validation (e.g., Trackwise, ZenQMS, Mastercontrol, ETQ).
- Familiarity with data integrity processes, including gap assessment, data criticality assessment, audit trail review, and e-record management.
- Strong skills in reviewing and approving quality assurance documentation.
- Excellent communication and collaboration skills.
- Ability to liaise effectively with stakeholders and clients to ensure compliance and project success.
