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 :

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.) .