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Niche regulated lab-systems expertise reduces applicant pool despite metro location.
Highly specialized regulated lab informatics skills limit transferability across industries.
Regulatory mandates, CSV/GxP expertise, and specific lab informatics experience make filters stringent.
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Serve as primary subject matter expert and technical lead for QC laboratory systems (e.g., CDS Empower, Moda EM).
Provide Level 3 support, manage system lifecycle, enhancements, and ensure compliance with GxP, 21 CFR Part 11, Annex 11, and data integrity standards.
Lead validation, compliance documentation, audit support, and drive continuous improvement in QC systems and laboratory processes.
Experience supporting and administering regulated QC laboratory systems like CDS Empower, Moda EM, WinKQCL, Tiamo, SoftMax Pro.
Strong knowledge of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and computer system validation (CSV) practices.
Bachelor's degree in Computer Science, IT, Life Sciences, Engineering, or equivalent experience.
Work Experience Required: Not explicitly mentioned in the JD. Office-first role based in Hyderabad with flexibility for 20% remote work.
Deep expertise in quality control systems within pharmaceutical, biotech, or life sciences regulated environments.
Experience collaborating with global cross-functional teams including QC, Quality Assurance, IT, Validation, and Compliance.
Ability to lead complex compliance activities (validation, audits) and manage multiple stakeholders effectively in regulated settings.