Senior Tech Specialist, Cloud Engineering - R01573611

Brillio; Bengaluru; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Brillio is seeking a Senior Tech Specialist, Cloud Engineering, in India to lead governance across cloud platforms with a strong emphasis on quality, CSV/CSA, and regulatory compliance. The role requires deep knowledge of GxP, 21 CFR Part 11, EU Annex 11, and data privacy.

You will drive qualification activities (IQ/OQ/PQ) for cloud environments and ensure audit readiness, partnering with QA, IT, and data governance teams. A Bachelor’s degree with relevant certifications is expected.

Qualifications

• Experience in IT Quality, CSV/CSA and IT Compliance in pharma or life sciences environments.
• Knowledge of GxP, 21 CFR Part 11, and EU Annex 11.
• Hands-on with IQ/OQ/PQ, system qualification, and validation of cloud-based or SaaS platforms.
• Proficient in validation docs, SOPs, URS, FS/DS, test scripts, and traceability matrices.
• Experience with SDLC and change management, release governance.

Responsibilities

• Drive governance across SDLC including design, development, release, change management and retirement with regulatory compliance.
• Plan and execute CSV/CSA activities using GAMP 5 risk-based methodologies.
• Lead qualification for systems, platforms, cloud environments, and sandboxes (IQ/OQ/PQ).
• Prepare and review Validation Plans, Risk Assessments, URS, FS/DS, Traceability, Test Scripts, Validation Summary Reports.
• Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11 and pharma standards.
• Develop and maintain SOPs, work instructions, system documentation, access reviews and periodic reviews.
• Manage document reviews and approvals using DocuSign or similar e-signature platforms.
• Coordinate with QA, IT, business owners, system owners, security and data governance teams for reviews.
• Manage deviations, CAPAs, change controls, and release approvals for audit readiness.
• Ensure GDPR/data privacy compliance including data classification and DPIA docs.
• Support AI/GenAI governance including risk assessments and oversight controls.
• Support internal audits and regulatory inspections with validated evidence and documentation.

Skills

IT Quality

CSV/CSA

GxP compliance

Regulatory standards

Cloud governance

Data privacy

AI governance

SDLC

Change management

IQ/OQ/PQ

Education

Bachelor's degree in Science/IT

ASQ CSQE

GAMP5 certification

ISO 27001

Tools

DocuSign

Snowflake

Power BI

Azure

AWS

Veeva Vault QualityDocs

Job description

Senior Tech Specialist, Cloud Engineering

Primary Skills

• PaaS - Oracle Integration Cloud, Cloud Health, Cloudlets, Powershell, Oracle Cloud Development (API, Data, Integration), Adobe Creative Cloud, Demandware / Commerce Cloud, Cloudcheckr, CloudHub/Mule, Open Stack, Informatica & ETL Tools, CloudForms, Cloud Storage

Specialization

• Cloud Platform consulting: Senior Tech Specialist, Cloud Engineering

Job requirements

• 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