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.) .