GxP Validation Specialist

4 weeks ago

Pune, Maharashtra, India Archimedis Full time

Position : GxP Validation Specialist

Experience : 5-6 Years

Location : Chennai / Pune

Employment Type : Full-time

Job Summary :

We are seeking a GxP Validation Specialist with 5-6 years of hands-on experience in Computer System Validation (CSV) and regulatory compliance within the life sciences domain. The ideal candidate will be an expert in ensuring systems adhere to GxP requirements and be responsible for the full validation lifecycle, from authoring validation deliverables to executing test cases. This role requires a strong understanding of 21 CFR Part 11 and Annex 11, as well as proficiency in SQL for database verification.

Key Responsibilities :

Validation & Compliance :

- Provide SME-level support in GxP compliance, Computer System Validation (CSV), and regulatory guidelines like 21 CFR Part 11 and Annex 11.

- Ensure all validation activities are aligned with a risk-based approach.

Test Case Management :

- Understand complex business and system requirements to author, review, and execute test cases for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)/User Acceptance Testing (UAT).

Documentation & Reporting :

- Author and review critical validation deliverables, including validation plans, summary reports, and traceability matrices.

- Use test management tools like HP ALM or Jira for defect logging, tracking, and resolution.

Technical Verification :

- Conduct SQL queries for database verification and support all database testing activities.

- Collaborate with business, QA, and IT teams to ensure full compliance with regulatory and quality standards.

Required Skills & Experience

Core Experience :

- 5-6 years of experience in GxP system validation, preferably within the life sciences industry.

- A solid understanding of CSV methodologies and risk-based validation approaches.

- Hands-on experience in preparing and executing IQ, OQ, and PQ/UAT test cases.

Technical Proficiency :

- Strong working knowledge of 21 CFR Part 11 and Annex 11.

- Proficient in SQL for data verification and database testing.

- Familiarity with test management tools like HP ALM or Jira.

Soft Skills :

- Excellent documentation, communication, and collaboration skills.

(ref:hirist.tech)

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