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:

CSV & Data Integrity Trainer

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.)

  .