Validation Analyst (GxP/CSV) (Canada)

Validation Analyst (GxP/CSV) (Canada)

03 Oct
|
Raas Infotek
|
Canada

03 Oct

Raas Infotek

Canada

We have an urgent position below. If you are interested, please share your updated resume with the rate expectation.

Role:- GRC Document Management Specialist

Location: Canada / Remote

Duration: Long term Contact

Detailed job Descriptions:-

This is a governance and operations role. It is not a software development position. The focus is platform administration, workflow management, access governance, and service process design.

Key Responsibilities

Validation Phase

- Submit and manage User Requirements for both the OT EDMS portal and EDMS viewer
- Coordinate with the EDMS technical team to gather any required metrics or inputs
- Lead sign-off of requirements and coordinate UAT testing across all user roles

Go-Live Preparation:-

- Conduct office hours for end users pre and post go-live
- Develop role-based training materials; create job aids as needed
- Build and maintain the IAM Security Matrix defining which roles require ISRM approval and which can be automated
- Coordinate with the IAM team on automation scoping and cost

Ongoing Platform Ownership:-

- Onboard new sites and manage onboarding of new users including author/approver role changes
- Enforce and assure document nomenclature standards across all submitted documents
- Monitor and resolve documents stuck in draft or approval stages; investigate and remediate stalled workflows
- Manage the security model and conduct periodic NAGS (access) reviews
- Maintain training content as the platform and processes evolve
- Field and resolve day-to-day portal questions from end users




- Track periodic document reviews to completion; manage late review handling and produce on-time/late metrics
- Process role approval requests in the IAM system

Migration

- Work with the EDMS technical team to migrate existing signed documents from Box into the new OT EDMS portal Service Design
- Partner with the client team to design the sustained operational process for OT threat detection as a service
- Help transition the current project-based model into a scalable, repeatable service model for new site onboarding

Required Qualifications

- Experience in GRC, document management, or quality systems operations
- Hands-on experience with a GxP-validated EDMS or quality management platform (e.g., Veeva, MasterControl, OpenText, ETQ, or similar)
- Understanding of document control workflows, approval routing, periodic review processes, and access governance
- Experience with IAM/access matrix design and role-based access management
- Familiarity with GxP validation activities including User Requirements, UAT, and sign-off processes
- Solid process design and documentation skills
- Ability to work independently under remote management across time zones

Preferred Qualifications:

- Familiarity with OT/ICS cybersecurity governance frameworks (NIST, IEC 62443)
- Prior experience with document migrations from Box or SharePoint into a formal EDMS
- Experience designing or transitioning project-based programs into service models
- Background in regulated industries (Life Sciences, Pharma, or similar GxP environments)

Thanks,

Elyash Khan

Raas Infotek

Newark, DE 19702

Direct number: (phone hidden) | 125

Email: [email protected]

📌 Validation Analyst (GxP/CSV) (Canada)
🏢 Raas Infotek
📍 Canada

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