Senior Computerized System Validation (CSV) & Data Integrity (ALCOA Principles)

Job Title : Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles)

Location : Remote

Job type : Part-time

Job Summary :

We are seeking a highly experienced CSV & Data Integrity Trainer with a strong background in regulatory compliance and hands-on experience in validating computerized systems used in GxP environments. The ideal candidate should have in-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles , and be capable of delivering engaging, practical training to QA, QC, Manufacturing, and IT professionals.

Key Responsibilities :

• Develop, design, and deliver training programs on Computerized System Validation (CSV) and Data Integrity (ALCOA & ALCOA+ principles) aligned with current regulatory guidelines.
• Train cross-functional teams on GAMP 5 lifecycle , risk-based validation approaches , Part 11 / Annex 11 compliance , and audit readiness .
• Conduct workshops and hands-on sessions on preparing Validation Master Plans (VMP), User Requirement Specifications (URS), Functional Specifications (FS), IQ / OQ / PQ protocols , and validation reports.
• Provide guidance on Data Integrity assessment, governance, risk mitigation, and remediation plans .
• Support in developing internal SOPs , policies , and training materials related to CSV and Data Integrity.
• Deliver training on Audit Trail Review , Backup / Restore validation , Change Control , and System Decommissioning .
• Evaluate and assess participants through tests, case studies, and practical sessions.
• Stay updated with evolving regulatory guidelines (USFDA, MHRA, WHO, EMA) and incorporate them into training content.
• Support in internal audits, gap assessments , and mock inspections related to computerized systems and data integrity.

Required Skills & Competencies :

Educational Qualification :

Preferred Background :