Principal - Business Consulting

Infosys; Bengaluru; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Infosys Consulting in Bengaluru seeks a senior professional with deep experience in Computerized System Validation and regulatory compliance within Life Sciences. You will drive validation activities for SAP/S4HANA, TrackWise, QMS and DMS, ensuring alignment with 21 CFR Part 11 and GxP standards.

The role requires strong risk management skills, audit readiness, and ability to lead multiple projects in a global delivery setup. IT validation excellence is central to delivery success.

Qualifications

• 12-20 years of professional experience in Life Sciences, within consulting or industry.
• Strong knowledge of 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing and approving validation deliverables.
• Familiarity with risk management and quality management requirements for IT projects.

Responsibilities

• Lead validation and compliance activities for enterprise applications (e.g., SAP/S4HANA, TrackWise, QMS, DMS).
• Assess regulatory readiness and ensure IT projects meet quality and regulatory requirements.
• Coordinate with cross functional teams and conduct audits and control maturity assessments.

Skills

CS Validation

Risk Management

Audits

GxP Compliance

Regulatory Knowledge

Education

Master of Pharmacy

MBA/PGDBA

Bachelor of Pharmacy (Honors)

Bachelor of Engineering

Tools

SAP/S4 HANA

TrackWise

QMS

DMS

Regulatory Systems

Job description

Job Description

Infosys is a global leader in next-generation digital services and consulting with annual revenues of $16.31B (FY '22). We enable clients in 46 countries to navigate their digital transformation

• Infosys Consulting partners with clients from strategy through execution to transform their businesses in areas such as business/ IT strategy, processes, organization, systems and risk. Infosys Consulting has 2,500+ people across the US, Europe, APAC and India
• We are Value Integrators - we deliver realized business value by managing transformations from strategy / setting direction through execution, including operating and optimizing delivered solutions
• IC-LS is dedicated to serving Life Sciences firms globally.

Roles & Responsibilities

We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation, Risk Management and Audits

• 12 - 20 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
• Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing and approving / acknowledging validation deliverables.
• Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
• Experience in validation of Enterprise applications such as SAP / S4 HANA projects, Trackwise, QMS, DMS and etc.
• Functional knowledge in any of the domain applications such as Clinical applications like EDC, CTMS etc., Regulatory applications like CDR, Oracle Argus, ArisGlobal LifeSphere, Veeva Vault or any other similar applications/system used in Pharma industry.
• Thorough Knowledge in compliance and validation concepts. (Change, Deviation, Supplier management)
• Experience in Agile and waterfall methodology
• Knowledge and hands on experience in conducting periodic or control maturity assessment and Audits
• Knowledge in Saas/Cloud Qualifications
• Knowledge of validation tools and templates used in the pharmaceutical industry.
• Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.
• Preferable IT background to understand complexities on the program.

Additional Responsibility

At IC-LS, you will:

• Be responsible for the delivery of business results to global health and life sciences clients.
• Serve as a team member, track lead or engagement lead on business consulting engagements for clients.
• Execute consulting engagements in a global delivery model, working with consultants across regions.
• Analyze problems, and structure complex business analyses.
• Work with cross functional client teams to perform gap analysis and identify improvement options.
• Effectively collaborate with the internal and external stakeholders.
• Participate in a variety of firm building events.

Educational Requirement

Master of Pharmacy,MBA PGDBA,Bachelor of Pharmacy (Honors),Bachelor of Engineering

Preferred Skills

Domain->Healthcare->Regulatory Compliance & Standards,Domain->LifeSciences->Pharma Regulations,Technology->Life Sciences->Regulatory Systems

Service Line

Infosys Consulting