Sr Analyst, Digital Core
Scorpion Therapeutics
Sr Analyst, Digital Core (Bangalore, India) Key Responsibilities Ensure early EQ involvement in application/infrastructure design/development so automated and preventive controls are built in. Own and lead end-to-end quality process/strategy; provide compliance guidance for applications and support infrastructure. Provide strategic direction and operational support; manage execution of TQ tasks to meet plans, goals, and timelines. Develop and contribute to qualification/validation strategies for new and emerging technologies. Maintain inspection readiness; participate in audits; approve non-conformity action plans and closures. Support incident management, CAPA, and non-conformance resolution for in-scope systems. Review/approve validation work and sign off on releases to production (e.g., compliance plans, UR/US, system tests, UAT, traceability matrices, compliance reports). Monitor alignment to SOPs/industry guidelines; collaborate on costs, schedules, resources, and quality. Partner cross-functionally to implement compliant solutions and communicate quality risks. Lead/mentor people; apply risk-based validation; manage consultants/vendors. Education (Required) Bachelor’s (or equivalent) in CS, IS, Business Admin, Science, Engineering, or related field. Required 2–4 years in pharma/med device/biotech with direct Computerized System Validation experience. Independent quality/validation task management; solutions-oriented, risk-based compliance. cGMP/CSV knowledge incl. 21 CFR Part 11, 210, 211, 820. Experience with qTest, Jira (Xray), Identity & Access Management; OT security tools. CI/CD tools: Jenkins, GitHub, Bitbucket, Artifactory. Cloud software quality experience (VPCx, cloud storage/compute, Kubernetes, Chef, etc.). Preferred Quality management system implementation; cybersecurity/privacy awareness; security role/SoD best practices. Audit/inspection readiness; digitization of validation processes. SDLC quality management + CSV/CSA; global regulations (EU Annex 11, SOX, HCC, Security/Privacy, ISO), GAMP 5 and ITIL. Agile/SAFe/RPA/IoT/Data & Analytics/AI/Intelligent Automation/Blockchain. Other Proficient English (written/oral). Up to 10% domestic/international travel may be required. #J-18808-Ljbffr Scorpion Therapeutics
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