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Validation Consultant Responsibilities and Duties

Develop and maintain validation documents for allotted products or projects.

Execute validation tasks to support validation and project plans.

Design validation plans and supervise execution of plans.

Report validation tasks on validation summary reports.

Supervise any deviation, respond to management team for every change control.

Identify revalidation requirement on basis of systems changes.

Manage adherence with 21 CFR Part 11 for assigned validation consultancy systems.

Ensure to collaborate with various information technology groups for verification of internal systems infrastructure.

Review entire internal documentation for conformance with regulations as well as industry guidelines.

Handle all external interactions pertinent to systems validation.

Participate in all internal, external as well as vendor audits.

Interact with peers and leaders in organization as component and necessity of compliance.

Report deviations as well as suggest remediation strategies for conformance gaps.

Provide technical writing assistance for IT Quality Management tasks.

Contribute to entire development as well as maintenance of policies and methods related to conformance activities.

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