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.) .
Required Skill Profession
Prb