Job Title: CSV-IT Specialist
Experience Required: 2–3 Years
Educational Qualification: B.Sc (IT) / M.Sc (IT)
Location: Ahmedabad
Job Description
We are seeking a motivated CSV-IT Specialist to join our team in Ahmedabad. The ideal candidate will focus on Computer System Validation (CSV) processes to ensure compliance with regulatory standards and optimize IT systems for operational excellence.
Key Responsibilities
CSV Process Management: Perform validation activities for IT systems, including documentation, testing, and implementation in compliance with GxP and regulatory guidelines.
System Development & Testing: Prepare validation plans, test cases, and protocols for IT systems, ensuring alignment with company and regulatory standards.
Risk Assessment: Identify, assess, and mitigate risks associated with IT systems and software applications.
Regulatory Compliance: Ensure IT systems comply with industry regulations such as 21 CFR Part 11, GAMP 5, and other relevant guidelines.
Documentation: Maintain comprehensive documentation of validation processes, including plans, test scripts, and deviation reports.
Collaboration: Work with cross-functional teams, including Quality Assurance, IT, and Operations, to implement and maintain validated systems.
Training: Provide training to staff on validated systems and ensure adherence to best practices.
Troubleshooting: Resolve technical issues related to IT systems and applications efficiently.
Candidate Requirements
Educational Background:
Bachelor's or Master's degree in Information Technology (B.Sc (IT) / M.Sc (IT)).
Experience:
2–3 years of relevant experience in Computer System Validation (CSV) within the IT or pharmaceutical industry.
Technical Skills:
Strong knowledge of validation processes, including IQ, OQ, PQ, and software testing methodologies.
Familiarity with regulatory requirements like FDA guidelines and EU Annex 11.
Proficiency in IT tools, including database management and ERP systems.
Soft Skills:
Excellent analytical and problem-solving skills.
Strong communication and interpersonal skills to collaborate with diverse teams.
Detail-oriented with the ability to manage multiple tasks efficiently.
Why Join Us?
Be part of a dynamic team driving compliance and innovation.
Opportunity to work on cutting-edge IT systems in a regulated environment.
Competitive salary and growth opportunities.
Access to continuous learning and professional development programs.
Take the next step in your IT career by applying for the CSV-IT Specialist role in Ahmedabad. Join us in creating compliant and efficient IT solutions for our organization!
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