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

Tek Supportrajahmundry, India

21 hours 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 • rajahmundry, India