SN Required Information Details
1 Role* Smart Solve (IQVIA) Product Consultant
2 Required Technical Skill Set** Strong hands-on expertise in Smart Solve (IQVIA) eQMS across core quality modules document control, training, deviations / nonconformance, CAPA, change control, audits, supplier quality, complaints, quality events, management review and reporting. Good understanding of the Smart Solve data model, configurable workflows, platform / deployment architecture, integration patterns with ERP, MES, LIMS, PLM, EDMS and LMS, reporting and analytics, licensing. Working knowledge of 21 CFR Part 11 / Part 820, EU Annex 11, EU MDR, ISO 13485 and GxP requirements applicable to eQMS evaluation and selection
4 Desired Experience Range** 8+ years in Life Sciences quality systems / eQMS consulting, with 4+ years hands-on Smart Solve (IQVIA) implementation, configuration, support or product evaluation engagements.
5 Location of Requirement India (Pune, Bangalore, Chennai)

Desired Competencies (Technical/Behavioral Competency)
Must-Have**
Proven hands-on Smart Solve (IQVIA) product experience, with the ability to demonstrate and articulate product capability against customer quality process requirements.
Ability to map harmonized eQMS requirements across the 13 quality domains to Smart Solve out-of-the-box, configurable and customization needs, and to document fit, gaps and workarounds.
Experience in product evaluation engagements weighted functional and non-functional scoring, scripted demonstration scenarios, RFP response analysis and reference checks.
Working knowledge of Smart Solve deployment options (cloud / on-premise), technical architecture, integration approaches, reporting / analytics and data migration considerations.




Exposure to GxP / validation-driven environments (CSV / CSA) and ability to ensure traceability of assessment deliverables to captured requirements.
Familiarity with Smart Solve licensing models, implementation and AMS cost drivers to support ballpark license and support cost inputs, along with cybersecurity / data privacy considerations (SOC 2, ISO 27001, GDPR).
Good-to-Have Exposure to comparable eQMS platforms such as Veeva Vault QMS and ETQ Reliance to support comparative evaluation.
Experience in biotech / CDMO or medical device quality operations and regulated manufacturing environments.
Solid workshop facilitation, documentation and executive presentation skills for client-facing scoring and recommendation sessions.

SN Responsibility of / Expectations from the Role
1 Participate in discovery and current-state assessment workshops and provide Smart Solve (IQVIA) product expertise to support definition and validation of high-level requirements.
2 Assess Smart Solve (IQVIA) capability against the harmonized eQMS requirements across the 13 quality domains and document product fit, gaps and configuration options.
3 Contribute to the evaluation methodology and weighted scoring criteria, and complete Smart Solve functional and non-functional scoring inputs during the product evaluation and scoring phase.
4 Support RFP development and administration, analysis of the Smart Solve vendor response, scripted demonstration scenarios and reference calls during the handover phase.
5 Provide ballpark Smart Solve license and AMS cost inputs and contribute to the executive decision package, weighted scoring summary and final recommendation, in line with SOW deliverables and review timelines.

📌 111135-1- SmartSolve (India)
🏢 Objectwin Technology India
📍 India