Role Overview:
The Validation Analyst is responsible for planning, executing, and documenting validation activities to ensure compliance with regulatory requirements (FDA, EMA, GxP, HIPAA, SOX) and internal quality standards. This role supports Computer System Validation (CSV), equipment qualification, and process validation across the organization.
Key Responsibilities:
• Develop and maintain validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.
• Perform Computer System Validation (CSV) activities in alignment with GAMP 5 and 21 CFR Part 11 guidelines.
• Ensure compliance with GxP, ICH Q9/Q10, and other applicable regulatory standards.
• Execute validation testing, record results, and manage deviations/CAPA as required.
• Collaborate with cross-functional teams (IT, QA, Manufacturing, R&D) for validation deliverables.
• Support audit readiness and respond to regulatory inspections.
• Maintain validation traceability matrices and ensure proper documentation control.
• Participate in periodic reviews and re-validation activities for systems and equipment.
Required Skills & Qualifications:
• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
• 2–5 years of experience in Validation, Quality Assurance, or Compliance within regulated industries.
• Strong knowledge of CSV principles, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and HIPAA.
• Familiarity with risk-based validation approaches and data integrity principles.
• Proficiency in documentation tools and MS Office Suite.
• Excellent analytical, problem-solving, and communication skills.
Preferred Qualifications:
• Experience with ERP/LIMS/Clinical Systems validation.
• Knowledge of automation tools and AI-enabled compliance workflows.
• Certifications such as ISPE GAMP, ASQ CQE, or CSV Specialist are a plus.