Senior Computerized System Validation

6 days ago

New Delhi, India Tek Support Full time

Job Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Location: Remote Job type: Part-timeJob Summary: We are seeking a highly experiencedCSV & Data Integrity Trainerwith 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 ofGAMP 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 onComputerized System Validation (CSV)andData Integrity (ALCOA & ALCOA+ principles)aligned with current regulatory guidelines. Train cross-functional teams onGAMP 5 lifecycle ,risk-based validation approaches ,Part 11 / Annex 11 compliance , andaudit readiness . Conduct workshops and hands-on sessions on preparingValidation Master Plans (VMP), User Requirement Specifications (URS), Functional Specifications (FS), IQ/OQ/PQ protocols , and validation reports. Provide guidance onData Integrity assessment, governance, risk mitigation, and remediation plans . Support in developing internalSOPs ,policies , andtraining materialsrelated to CSV and Data Integrity. Deliver training onAudit Trail Review ,Backup/Restore validation ,Change Control , andSystem Decommissioning . Evaluate and assess participants through tests, case studies, and practical sessions. Stay updated with evolvingregulatory guidelines (USFDA, MHRA, WHO, EMA)and incorporate them into training content. Support ininternal audits, gap assessments , andmock inspectionsrelated to computerized systems and data integrity.Required Skills & Competencies: Strong knowledge ofGAMP 5 ,21 CFR Part 11 ,Annex 11 ,MHRA DI guidance ,WHO TRS 1019 , and related frameworks. Hands-on experience inCSV lifecycle management ,risk assessment ,change control , andperiodic review . Expertise inData Integrity principles (ALCOA/ALCOA+) ,data lifecycle management , andgovernance frameworks . Experience withLIMS, 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.Techin Life Sciences, Computer Science, Instrumentation, or related fields. Certification inGAMP 5 / CSV / Data Integrity / Regulatory Compliancewill be preferred.Preferred Background: Experience inregulated industries(Pharma, Biotech, or Medical Devices). Prior experience as atrainer, consultant, or auditorin CSV and Data Integrity domains. Exposure toglobal regulatory audits (USFDA, MHRA, TGA, WHO, EMA, etc.) .

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