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Senior Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Job Opening In vadodara – Now Hiring Tek Support

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

    India Jobs Expertini Expertini India Jobs Vadodara Other General Senior Computerized System Validation (Csv) & Data Integrity (Alcoa Principles)

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

Other General


  • Job Details

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Tek Support hiring Senior Computerized System Validation (CSV) & Data Integrity (ALCOA Principles) Job in thiruvananthapuram, thiruvananthapuram, India
Tek Support
thiruvananthapuram, thiruvananthapuram, India

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