Lead Pharma Solution Architect

Capgemini Engineering; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Capgemini Engineering in Pune is seeking a Lead Pharma AMS professional to drive assessments, solution design, and delivery excellence across the Pharma landscape including R&D, Labs, Clinical, Manufacturing, Quality, Regulatory and TechOps.

You will lead workshops, estimations, vendor evaluations, transformation roadmaps and proposal leadership with focus on GxP, CSV, 21 CFR Part 11 and Data Integrity.

Qualifications

• Bachelor's or master's in engineering, Pharmacy, Biotechnology, Life Sciences or equivalent.
• Relevant Pharma domain experience and strong stakeholder communication.

Responsibilities

• Lead Pharma AMS assessments, solution design, proposal support and delivery excellence across Pharma R&D, Labs, Clinical, Manufacturing, Quality, Regulatory, TechOps and enterprise integrations.
• Portfolio analysis, workshops, solution design, estimation, vendor evaluation, application rationalization, stakeholder management, transformation roadmap development.

Job description

Lead Pharma AMS assessments, solutioning, proposal support and delivery excellence within Life Sciences.

Key Responsibilities: Portfolio analysis, workshops, solution design, estimation, vendor evaluation, application rationalization, stakeholder management, transformation roadmap development.

Domain Scope: Pharma R&D, Labs, Clinical, Manufacturing, Quality, Regulatory, TechOps, Commercial and enterprise integrations.

Mandatory Pharma Platforms: Pharma value chain, GxP, CSV, AMS estimation, application rationalization, transformation roadmap, proposal leadership

AMS Proposal Responsibilities: Application inventory assessment, criticality mapping, support model definition, transition planning, effort estimation, SLA/KPI framework, modernization recommendations and risk assessment.

Regulatory & Compliance Expectations: GxP, GAMP5, 21 CFR Part 11, Annex 11, Data Integrity, CSV, audit readiness and validation lifecycle awareness.

Required Qualifications: Bachelor/master's in engineering, Pharmacy, Biotechnology, Life Sciences or equivalent; relevant Pharma domain experience; strong stakeholder communication.

Preferred Qualifications: Global delivery experience, Agile/SAFe knowledge, cloud platforms, AI/Data exposure, relevant platform certifications.