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Experience Range: with at least 6 years of experience in IT quality, system validation, and compliance for cloud platforms within the pharmaceutical or life sciences industry Key Responsibilities: 1. Drive IT platform and application governance throughout the system development lifecycle, including design, development, release, change management, and retirement, ensuring regulatory compliance 2. Plan and execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities using risk-based GAMP 5 methodologies 3. Lead qualification activities for systems, platforms, cloud environments, and sandboxes, including IQ/OQ/PQ 4. Prepare and review validation documentation such as Validation Plans, Risk Assessments, URS, Functional Specifications, Traceability Matrices, Test Scripts, and Validation Summary Reports 5. Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and applicable pharmaceutical regulatory standards 6. Develop, maintain, and review SOPs, work instructions, system documentation, configuration records, access reviews, and periodic review documents 7. Manage document review and approval workflows using DocuSign or similar e-signature platforms 8. Coordinate with QA, IT, business owners, system owners, security, and data governance teams to obtain necessary reviews and approvals 9. Manage deviations, CAPAs, change controls, and release approvals, ensuring timely closure and audit readiness 10. Ensure GDPR and data privacy compliance, including data classification, data handling, and DPIA documentation 11. Support AI/GenAI governance activities, including model risk assessments, intended-use documentation, human oversight, and monitoring controls 12. Support internal audits, regulatory inspections, and compliance assessments by maintaining appropriate validation evidence and documentation Required Skills: 1. Expertise in IT Quality, Computer System Validation (CSV/CSA), and IT Compliance within pharmaceutical or life sciences environments 2. Strong knowledge of GxP, GAMP 5, 21 CFR Part 11, and EU Annex 11 3. Hands-on experience with IQ/OQ/PQ, system qualification, and validation of cloud-based and SaaS platforms 4. Proficiency in validation documentation, SOPs, URS, FS/DS, test scripts, traceability matrices, and validation reports 5. Experience with SDLC, IT change management, release management, and system lifecycle governance 6. Experience with DocuSign or similar electronic signature and document approval platforms 7. Understanding of GDPR, data privacy, deviations, CAPA, and change control processes 8. Familiarity with AI/GenAI governance and risk management requirements Preferred Skills: 1. Experience with Snowflake, Power BI, Azure, AWS, or other data and analytics platforms in regulated environments 2. Familiarity with ServiceNow, Veeva Vault QualityDocs, or similar quality management systems 3. Knowledge of EU AI Act, NIST AI Risk Management Framework, or enterprise AI governance policies Desired Qualifications: 1. Bachelor's degree in Computer Science, Information Technology, Pharmaceutical Sciences, or a related field 2. Certification in ASQ CQA/CSQE, GAMP 5, or ISO 27001 Additional Information: Location: India
