(Remote) Senior CSV Validation Specialist-12-15 Years-Immediate Joiners only
2 weeks ago
SpurQLabs is an independent software testing and test automation company committed to helping clients build exceptional quality products at speed. We offer specialized services in test automation, performance testing, API testing, and CI/CD. With a vision to support clients in delivering secure, scalable, and reliable software, SpurQLabs emphasizes regulatory compliance, efficiency, and quality.
Job Summary:
We are looking for a Senior CSV Validation Specialist to join our team and support validation activities for GxP-compliant systems in the pharmaceutical or life sciences domain. This role will focus on drafting, reviewing, and executing validation protocols (IQ/OQ/PQ), identifying and managing system risks, and maintaining traceable documentation to meet global regulatory standards such as GxP, GAMP 5, and 21 CFR Part 11.
Key Responsibilities:
Validation Execution:
- Create, review, and execute validation protocols (IQ/OQ/PQ) in alignment with GxP and GAMP 5 guidelines.
- Develop and maintain validation plans, traceability matrices, and test scripts to ensure compliance.
Risk-Based Validation:
- Integrate functional risk assessment outcomes into OQ protocol development to focus on critical functionalities and potential failure points.
- Contribute to system risk level assessments to determine the impact of identified risks on the validated state.
Documentation & Compliance:
- Maintain accurate validation documentation that adheres to GDP (Good Documentation Practice).
- Support periodic review of validation deliverables to ensure ongoing compliance with FDA 21 CFR Part 11 and relevant GxP regulations.
Defect Management:
- Identify, log, and track software/system defects during testing phases.
- Collaborate with development and QA teams to ensure timely resolution.
Technical Skills:
- Strong foundation in SQL for data validation and querying during test execution.
- Basic familiarity with validation tools and documentation systems.
Deliverables:
- Validation Plan
- User Requirements/Functional Specifications/Design Configuration
- Risk Assessments
- Design Qualification / Vendor Supplied Documents
- Installation/Operation/Performance Qualification & Test Scripts
- Traceability Matrix
- Validation Summary Report
Required Skills & Qualifications:
- Bachelor’s degree in Life Sciences, Biotechnology, Computer Science, or related technical field.
- 12 to 15 years of hands-on experience in GxP computer system validation.
- Strong working knowledge of:
- GxP, GAMP 5, and GDP principles
- FDA 21 CFR Part 11 regulations
- Validation lifecycle documentation (IQ, OQ, PQ, RTM, VSR)
- Experience working in regulated industries such as pharma, biotech, or medical devices.
- Proficiency in SQL and understanding of relational databases.
- Excellent communication, documentation, and collaboration skills.
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