Overview
Remote
On Site
Full Time
Skills
GxP
Test Plans
Scripting
Risk Assessment
Documentation
Computerized System Validation
Regulatory Compliance
IQ
OQ
PQ
Traceability Matrix
Risk Analysis
Collaboration
Information Systems
Management
SAP BASIS
Job Details
Roles & Responsibilities:
- Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
- Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
- Compliance Analysis, Validation Planning, Risk Assessments
- Test planning and strategy creation and execution of test protocols, scripts and reports.
- Validation Summary Reports, traceability analysis.
- Defect Logging and Tracking till closure.
- Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
- Author and update documentation to support ongoing CSV compliance.
- Prepare or review all levels of validation documents including Validation (Strategy) Plans, User Requirement Specifications.
- Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs.
- Qualification Documents and Test Specifications (IQ, OQ, PQ) Traceability Matrices, Risk Analysis.
- Validation Reports, Change Controls/ Events / Deviations etc.
- Assess the impact of changes proposed to computerized systems and the level of change required.
- Provide validation strategy to the introduction of computerized systems.
- Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc.) and management on all related matters on a regular basis.
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