Job highlights

- The role bridges laboratory users and technology delivery teams by translating scientific and quality processes into standardized LIMS workflows,master data,functional requirements,test scenarios,and sustainable global ways of working
- Partner with Quality to assess process impacts,address observations,and drive sustainable remediation where required. . What You Should Bring

Job Role Job Role: QC Labs Ops LIMS Process Expert

Role Overview

This role is for Manufacturing Quality and provides deep pharmaceutical QC process expertise, including the scientific processes performed on laboratory equipment, to support the design, harmonization, implementation, and deployment of LabVantage and connected laboratory solutions across the manufacturing network. The role bridges laboratory users and technology delivery teams by translating scientific and quality processes into standardized LIMS workflows, master data, functional requirements, test scenarios, and sustainable global ways of working.

Key Responsibilities

- QC Process Expertise Harmonization Serve as a subject-matter expert for end-to-end pharmaceutical QC laboratory processes and LIMS-enabled workflows.
- Lead process mapping, fit-gap assessment, harmonization, and standardization across sites; identify justified local or regulatory variations.
- Promote MQ Labs standards, reusable process patterns, and best practices while challenging unnecessary customization.
- Facilitate global workshops with QC scientists, laboratory SMEs, Quality, product owners, and implementation partners to drive process decisions and adoption.
- LabVantage Implementation Functional Design Participate across LabVantage requirements, design, configuration review, demonstrations, testing, validation, deployment readiness, and post-deployment stabilization.
- Translate QC laboratory needs into clear functional requirements, process flows, user stories, acceptance criteria, and intended-use scenarios.
- Review proposed configurations and workflows for scientific fit, usability, compliance, standardization, and alignment with approved global processes.
- Support fit-gap decisions, functional issue resolution, defect triage, and business acceptance throughout the implementation lifecycle.




- Laboratory Processes Master Data Provide process expertise across sample receipt and lifecycle, specifications, analytical methods, tests, parameters, limits, result entry and review, approval, and release-support workflows.
- Define and harmonize requirements for stability programs, sterility testing, environmental monitoring, exceptions, investigations, retesting or resampling, and related QC workflows.
- Apply practical understanding of laboratory equipment processes, analytical data generation, review controls, instrument outputs, and relevant ICH expectations.
- Partner on laboratory master-data design, governance, creation, migration, verification, and lifecycle maintenance to ensure accuracy, consistency, traceability, and reuse.
- Ensure master-data structures and workflows reflect approved laboratory processes and support efficient global deployment.
- Connected Laboratory Process Design Define business-process and data requirements for connections between LabVantage and laboratory systems.
- Provide process expertise for flows involving Empower/CDS, MODA-EM, ELN/LES, MES, SAP, and connected analytical instruments.
- Define business ownership, source and target data expectations, exception-handling scenarios, reconciliation needs, and user workflows for integrations.
- Identify opportunities to reduce manual transcription, simplify handoffs, and enable straight-through laboratory data flows.
- Partner with technical integration and platform teams while remaining focused on process, data, and functional requirements rather than infrastructure or driver engineering.
- Testing, Validation Deployment Readiness Develop and review business-process test scenarios and acceptance criteria; support functional testing, UAT, validation, and defect triage.
- Partner with Quality and validation/CSQA teams to ensure intended use, requirements, testing, traceability, and process controls are appropriately addressed.
- Support site readiness, SOP and process alignment, training content,



cutover planning, adoption, and hypercare from a QC-process perspective.
- Ensure deployed workflows remain aligned with approved global processes and drive feedback into continuous improvement and future releases.
- Governance, Data Integrity Regulatory Compliance Apply GxP, data integrity, ALCOA+, 21 CFR Part 11, EU Annex 11, applicable ICH expectations, and risk-based CSV/CSA principles to LIMS process design and use.
- Ensure process requirements address appropriate review, approval, audit trail, electronic-record, traceability, and exception-management expectations.
- Support inspection readiness and provide QC/LIMS process expertise during USFDA, EMA/EMEA, and other regulatory inspections and audits.
- Partner with Quality to assess process impacts, address observations, and drive sustainable remediation where required.

What You Should Bring

- Deep pharmaceutical or biotechnology QC laboratory-process expertise.
- Hands-on understanding of LIMS-enabled laboratory workflows and experience participating in LabVantage or a comparable enterprise LIMS implementation.
- Strong experience with process harmonization, fit-gap analysis, functional requirements, laboratory master data, testing/UAT, validation, and deployment readiness.
- Practical knowledge of stability, sterility, environmental monitoring, sample management, analytical testing, specifications, results review, investigations, and release-support processes.
- Understanding of the scientific processes performed on common QC laboratory equipment and how results, metadata, controls, and exceptions are managed.
- Understanding of business and data flows involving Empower/CDS, MODA-EM, MES, SAP, ELN/LES, instruments, or related laboratory applications.
- Strong facilitation, stakeholder management, global collaboration, problem-solving, and change-adoption skills.
- Solid understanding of GxP, data integrity, CSV/CSA, ICH expectations, and regulatory inspection expectations for laboratory computerized systems.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 QC Labs Ops & LIMS Process Expert (Hyderabad)
🏢 Eli Lilly
📍 Hyderabad