Computer System Validation
3 days ago
Key Responsibilities:
- Develop and execute test cases, test scripts, and validation protocols (IQ, OQ, PQ) in accordance with approved procedures.
- Prepare validation deliverables URS, Validation Plan, Traceability Matrix, Test Summary Reports, and Deviations.
- Support and coordinate validation testing activities under QA oversight.
- Ensure all documentation and test evidence meet data integrity (ALCOA+) and GxP compliance requirements.
- Participate in defect tracking, test incident resolution, and retest documentation.
- Collaborate with QA validation teams during review and approval of CSV deliverables.
- Contribute to change control, periodic review, and system revalidation activities.
- Maintain accurate audit-ready documentation for all validation activities.
Qualifications and Requirements:
- Bachelors degree in Engineering, Computer Science, Life Sciences, or related discipline.
- 3-6 years of experience in Computer System Validation within GxP-regulated environments.
- Proven experience in test case drafting, execution, and validation reporting.
- Exposure to validation of systems such as MES, LIMS, DCS/PLC, ERP, or other computerized systems.
- Sound understanding of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
- Strong documentation and analytical skills.
- Ability to work collaboratively with QA, IT, and Engineering functions.
Job Types: Full-time, Contract
Contract length: 24 months
Pay: $6, $8,000.00 per month
Benefits:
- Health insurance
Work Location: In person
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