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.
- Valuable 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

- 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

📌 Principal - Business Consulting (Bengaluru)
🏢 Infosys
📍 Bengaluru