Validating Computer Systems Specialist

2 days ago

Gurgaon, Haryana, India beBeeComputerSystemValidation Full time ₹ 1,04,000 - ₹ 1,30,878
Job Summary:

The Computer System Validation (CSV) Engineer is responsible for ensuring that computerized systems used in regulated environments meet regulatory compliance requirements. This role involves planning, authoring, reviewing, and executing validation deliverables.

Key Responsibilities:

1. Develop and execute validation strategies and plans for new and existing computerized systems.

2. Create and maintain validation documents including User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Validation Plans (VP), IQ/OQ/PQ Protocols and Reports, and Traceability Matrix.

3. Ensure compliance with FDA regulations, EMA guidelines, and GAMP 5 standards.

4. Collaborate with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure system functionality meets business and regulatory needs.

5. Perform impact assessments and change control activities for validated systems.

6. Support data integrity initiatives and ensure systems comply with 21 CFR Part 11 requirements.

7. Provide training and guidance on CSV processes and best practices.

8. Maintain validation documentation in alignment with company procedures and regulatory expectations.

Required Skills and Qualifications:

Education: Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.

Experience: 2–5+ years of experience in CSV within regulated industries (pharma, biotech, medical devices).

Skills & Knowledge: Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11. Understanding of software development life cycle (SDLC) and risk-based validation approaches.

Preferred Qualifications: CSV certifications (e.g., ISPE, PDA) or GxP training. Experience in data integrity assessments and remediation projects.

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