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

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

Tek Supportnagpur, India
5 days ago
Job description

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 :

  • Strong knowledge of GAMP 5 , 21 CFR Part 11 , Annex 11 , MHRA DI guidance , WHO TRS 1019 , and related frameworks.
  • Hands-on experience in CSV lifecycle management , risk assessment , change control , and periodic review .
  • Expertise in Data Integrity principles (ALCOA / ALCOA+) , data lifecycle management , and governance frameworks .
  • Experience with LIMS, ERP, SCADA, DCS, MES, QMS, and laboratory instruments .
  • Excellent presentation, communication, and interpersonal skills.
  • Ability to simplify complex technical concepts into understandable, practical learning modules.

    • Educational Qualification :

  • B.Pharm / M.Pharm / B.Sc / M.Sc / B.E / M.Tech in Life Sciences, Computer Science, Instrumentation, or related fields.
  • Certification in GAMP 5 / CSV / Data Integrity / Regulatory Compliance will be preferred.

    • Preferred Background :

  • Experience in regulated industries (Pharma, Biotech, or Medical Devices).
  • Prior experience as a trainer, consultant, or auditor in CSV and Data Integrity domains.
  • Exposure to global regulatory audits (USFDA, MHRA, TGA, WHO, EMA, etc.) .
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    Computerized System Validation Csv • nagpur, India

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