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8.0 - 13.0 years
20 - 30 Lacs
Hyderabad, Pune, Bengaluru
Hybrid
Dear Candidate Hope you are doing well My name is Bhavani, I am a recruiter from Yallas Technology solutions We are Hiring a job opportunities. please find the position details below. Title: Computer System Validation (CSV) Expert( SAP CSV) Duration: Permanent Position Location: Hybrid/work from home(if client asked, need to work at client location) Notice period- Immediate - 7 days Job Description: You have successfully completed studies in the field of computer science, engineering or a related field. • You are passionate about ensuring compliance and quality in software solutions tailored for the life sciences industry. • You have minimum of 5 years proven experience in the field of CSV / GxP, ideally at a software supplier for the regulated industry. • You have a deep understanding of GxP regulations (such as FDA 21 CFR Part 11, Annex 11, GAMP 5), and HIPAA requirements for handling and securing health-related data. • Strong knowledge of data integrity principles (ALCOA+) and security best practices in validated environments. • You are familiar with risk-based approaches and have a solid understanding of risk management practices in regulated environments. • Experience in preparing, and supporting regulatory audits and inspections, with an emphasis on CSV, GxP, and data privacy regulations such as HIPAA. • You have a problem-solving mindset with strong analytical skills allowing you to identify and address compliance risk and process improvements. • You have a high attention to detail to ensure compliance and qualification accuracy. • You are proactive, you value collaboration & teamwork, and you communicate excellently. • Fluent in English, any additional language is a plus If you are interested please share required details along with resume Full Name: Current or Previous organization: Current Location: Total Experience: Relevant experience as SAP CSV: how many years of experience in CSV: How many years of experience in GxP, and HIPAA: Working as full time or contract: Reason for job change: Any other offers inhand: Are you ready to work at office?: Current CTC: expected CTC: Notice Period: email id: contact Number : Domain name: Thanks & Regards Bhavani Jagannadha Senior IT Recruiter
Posted 2 months ago
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