Life Sciences Management Consultant

Infosys; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Infosys IC-LS division seeks a senior consultant to drive validation programs for life sciences clients in a global delivery setup. You will lead efforts on CSF/IT validation, ensure compliance with 21 CFR Part 11 and related GxP standards, and coordinate across SAP/S4HANA, TrackWise, QMS, and DMS environments.

The role requires expertise in clinical/regulatory domain applications and strong process governance within Agile and waterfall frameworks, based in Bengaluru.

Qualifications

• 12–20 years of experience in Life Sciences consulting or industry.
• Strong knowledge of 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management and quality management for IT projects.
• Experience validating enterprise applications (SAP/S4HANA, TrackWise, QMS, DMS).
• Domain knowledge in Clinical (EDC, CTMS) or Regulatory (CDR, Oracle Argus, LifeSphere).
• Proficient in Agile and Waterfall methodologies.
• Experience with SaaS/Cloud qualifications and validation tools.

Responsibilities

• Deliver business results to global health and life sciences clients.
• Serve as team member, track lead or engagement lead on consulting engagements.
• Execute engagements in a global delivery model with cross-region consultants.
• Analyze problems and structure complex business analyses.
• Collaborate with internal and external stakeholders across projects.

Skills

CSVV knowledge

Risk management

Audits

GxP compliance

Regulatory compliance

Tools

SAP/S4HANA

TrackWise

QMS

DMS

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.
  

• 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.
  

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. 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, 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.