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Senior QA and IT Infrastructure Specialist to support the implementation and validation of IT i[]

3 months ago

Montreal Quebec GF, CA S.i. Systems Full time

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Our 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:
  1. Review and approve validation documentation for regulatory and GMP compliance purposes.
  2. Ensure the documentation includes risk assessments, validation protocols, reports, deviations, gap assessments, and validation plans.
  3. Review and approve Change Requests related to the project for compliance with applicable regulations and CTMF procedures.
  4. Review and approve quality assurance procedures, including computerized systems procedures, data integrity, backup and restore SOPs, disaster recovery SOPs, and audit trail reviews.
  5. Provide quality assurance for validation and data integrity documentation related to Trackwise digital upgrades and implementation of an Inventory warehouse management cloud system.
  6. Optionally, provide GMP compliance support and training to IT and automation teams.
Must Haves:
  1. 10+ years of experience in GMP regulation in the biopharma/pharmaceutical industry.
  2. 5+ years of experience as QA.
  3. 5+ years of experience in software/equipment validation or QA validation.
  4. Experience in at least one project in cloud software validation or QA validation.
  5. Experience in at least one project in QMS software validation (e.g., Trackwise, ZenQMS, Mastercontrol, ETQ).
Nice to Haves:
  1. Familiarity with data integrity processes, including gap assessment, data criticality assessment, audit trail review, and e-record management.
  2. Strong skills in reviewing and approving quality assurance documentation.
  3. Excellent communication and collaboration skills.
  4. Ability to liaise effectively with stakeholders and clients to ensure compliance and project success.
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