Senior Computerized System Validation

5 hours ago

Thane, India Tek Support Full time

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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