Sr. CSV Validation Lead/Engineer _ Bothell, WA ( Day1 onsite)

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 12 Month(s)

Skills

CSV
Validation
21 CFR Part 11
Gxp
GAMP

Job Details

Requirement details:

Job Title: Sr. CSV Validation Lead/Engineer

Location: Bothell, WA ( onsite)

Duration : 12+ Months

Job Description:

8-10+ Years of Overall IT Experience

Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix.

Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review.

Participate in establishing standard quality and validation practices Independently assess compliance practices and recommend corrective actions.

Approve validated computer system related change requests Monitor regulatory and inspection trends and advise the business on suitable action.

Ability to create documents to an existing document standard.

Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.

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