IN-Manager_CSV_ITRA_Advisory_Hyderabad
On-siteHyderabad, Telangana, India
Job Summary
Execute Computer System Validation (CSV) activities including authoring deliverables such as Validation Plans, User Requirement Specifications, Functional Risk Assessments, and IQ/OQ/PQ protocols. Manage Change Control, Deviation Management, and CAPA processes while ensuring compliance with GAMP5, GxP, US FDA 21 CFR Part 11, and EU Annex 11 standards. Lead manual testing efforts covering positive, negative, regression, smoke, and sanity testing, utilizing tools like Valgenesis and LIMS/QMS where applicable. Requires 4-12 years of experience in SDLC/STLC, Waterfall/Agile/V-model methodologies, and defect tracking. No work visa sponsorship available.
Required Qualifications
- 4-12 years of work experience in Computer System Validation (CSV)
- Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC)
- Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV
- Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting
- Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles
- Knowledge of Change Control, Deviation Management, CAPA and Periodic Review
- Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR)
- Bachelor of Technology
- Bachelor of Engineering
Desired Qualifications
- Preferred exposure to CSV tools such as Valgenesis
- LIMS/QMS
- Certifications
- Creating Shared Value (CSV)
- Accounting and Financial Reporting Standards
- Active Listening
- Analytical Thinking
- Artificial Intelligence (AI) Platform
- Auditing
- Auditing Methodologies
- Business Process Improvement
- Coaching and Feedback
- Communication
- Compliance Auditing
- Corporate Governance
- Creativity
- Data Analysis and Interpretation
- Data Ingestion
- Data Modeling
- Data Quality
- Data Security
- Data Transformation
- Data Visualization
- Embracing Change
- Emotional Regulation
- Empathy
- Financial Accounting
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