Senior Computerized System Validation
1 week ago
Job Title: Senior Trainer – Computerized System Validation (CSV) & Data Integrity (ALCOA Principles)Location: Remote Job type: Part-timeJob 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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Senior Computerized System Validation
7 days ago
bangalore, India Tek Support Full timeJob 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...
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Senior System Integration
2 weeks ago
bangalore, India Schneider Electric Full timeJob Title: Senior System Integration & Validation EngineerLocation: Bangalore, IndiaDepartment: Digital BuildingsPosition Type: Full-Time / ContractTravel Required: No Position Overview:We are looking for a highly experienced Senior System Integration & Validation Engineer to lead large-scale system integration efforts and end-to-end validation workflows...
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Senior System Integration
2 weeks ago
bangalore, India Schneider Electric Full timeJob Title: Senior System Integration & Validation Engineer Location: Bangalore, India Department: Digital Buildings Position Type: Full-Time / Contract Travel Required: No Position Overview: We are looking for a highly experienced Senior System Integration & Validation Engineer to lead large-scale system integration efforts and end-to-end validation...
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Senior Qa Analyst
4 weeks ago
Bangalore, Karnataka, India IQVIA Full timeBachelor s degree in engineering science 3 years of experience exposure to Computerized System Validation CSV US FDA 21 CFR Part 11 EU Annex 11 and GAMP 5 Experience with the implementation of Quality Management systems Track wise Master control ETQ CEBOS Should be able to Develop validation documentation for pharmaceutical equipment facilities and...
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Bangalore, Karnataka, India AstraZeneca Full timeJob Title Senior IT Validation Engineer Quality and Laboratory Systems Work Location Manyata Tech Park Bangalore India Work Schedule Three days on-site two days remote 3 2 Career Level D3 - Individual Contributor position Introduction to role Are you ready to make a difference in the world of rare diseases At Alexion AstraZeneca Rare Disease we are committed...
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Senior Infrastructure Test
1 week ago
Bangalore, India People Prime Worldwide Full timeAbout Company: Our Client Corporation provides digital engineering and technology services to Forbes Global 2000 companies worldwide. Our Engineering First approach ensures we can execute all ideas and creatively solve pressing business challenges. With industry expertise and empowered agile teams, we prioritize execution early in the process for impactful...
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Senior Infrastructure Test
1 week ago
Bangalore, India People Prime Worldwide Full timeAbout Company: Our Client Corporation provides digital engineering and technology services to Forbes Global 2000 companies worldwide. Our Engineering First approach ensures we can execute all ideas and creatively solve pressing business challenges. With industry expertise and empowered agile teams, we prioritize execution early in the process for impactful...
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Validation Lead
1 week ago
Bangalore, India Zeno Full timeZeno is seeking a Battery Validation Lead to establish and lead validation efforts for Zeno’s battery systems. Bengaluru – Work from Office (5 days a week) Start Date: Immediate An unprecedented energy transition has begun. To meet 2040 net zero goals, over 2 billion electric two-wheelers (motorcycles) must be sold and $11 trillion in fuel consumption...
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Validation Lead
2 weeks ago
bangalore, India Compliance Group Inc Full timeWe are looking for Validation Lead for Compliance Group Inc. High preference to short notice period.Experience : 6 to 12 yearsLocation: Hyderabad (Remote)Develop and implement validation strategies and processes to ensure the quality and reliability of products throughout the development lifecycle.Collaborate with cross-functional teams including...
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Senior Infrastructure Test
2 weeks ago
bangalore, India People Prime Worldwide Full timeAbout Company: Our Client Corporation provides digital engineering and technology services to Forbes Global 2000 companies worldwide. Our Engineering First approach ensures we can execute all ideas and creatively solve pressing business challenges. With industry expertise and empowered agile teams, we prioritize execution early in the process for impactful...
