CSV Analyst / System Validation Analyst

Overview

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

Skills

IQ/OQ/PQ/OPQ
21 CFR Part 11
CSV
System Validation
Annex 11
GAMP 5
validation documents

Job Details

POSITION GENERAL DUTIES AND TASKS -
QA System Validation Supervisor with 8+ Years exp
Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5
Updates validation procedures, including change control, training, and audits, to ensure the maintenance of system validation.
Writes and reviews technical validation documents (e.g., validation plan, URS, FRS, Risk Assessment, Traceability Matrix, IQ/OQ/PQ/OPQ protocol, report, etc.)
Assists in system validation project activities (e.g., writing protocols, reviewing/approving test scripts, drafting validation reports, etc.)
Review and approve Change Control requests and assesses the impact on system validation status.
Review and approve procedures, forms, and manuals.
Perform audit trail reviews and document results.
Perform system validation status evaluations and complete reports.
Assist with supplier qualification assessment data gathering.
Investigate, review, approve, and perform corrective actions for deviations (i.e., nonconformances and CAPAs) and audit findings.
Maintains the document management system for healthcare facilities and distribution centers to ensure required documents and data are available for regulatory agency audits and inspections
Supports internal and external audits
Supports validation project status reports to communicate project goals, contingency plans, and issue resolutions to project teams and clients

Tasks identified:
Provides guidance to UPS Supply Chain Solutions (SCS) Information Technology (IT) and Engineering departments to maintain validation of warehouse and/or support systems utilized for healthcare applications.
Identify systems used in healthcare that require validation and assess and evaluate the applications for system validation requirements.
Consults with internal groups (e.g., Operations, Business Development, IT, etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.
Mandatory Skills:
Proficient with Microsoft Office applications (Word, Excel, and PowerPoint)

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