Computer System Validation Engineer
Computer System Validation Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
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 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.
Employment Type
Remote
Company Industry
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
