Infosys Consulting · 1 day ago
Senior Consultant- Computer System Validation- Life Sciences
Indianapolis, IN
Full-time
Onsite
Senior Level
$130K/yr - $177K/yr
5+ years expInfosys Consulting is seeking a Senior Consultant in Computer System Validation within the Life Sciences domain. The role involves overseeing validation deliverables, ensuring compliance with IT system development processes, and guiding project teams on validation and compliance requirements.
ConsultingHuman ResourcesInformation Technology
No H1B
Responsibilities
Create, review, and approve validation deliverables
Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure followed compliance in each release /Iteration
Working experience on Agile/JIRA, Confluence, ALM
Author major project validation deliverables as per client’s standard operating procedures
Review and approve system lifecycle deliverables generated by project team
Guide project teams on applicable validation, security, and project management deliverables
Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development
Contribute to internal and external audits, assessments, or inspections
Escalate critical compliance findings, risks, or issues into appropriate client units
Prepare management reports regarding compliance operations and progress
Qualification
Required
5 plus 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 validation deliverables
Knowledge of risk management processes
Thorough knowledge in compliance and validation concepts
Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments
Strong understanding of pharmaceutical compliance regulations and validation concept
Experience with Agile and Waterfall methodologies
Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM
Ability to manage multiple projects and adapt to complex environments
Excellent communication and collaboration skills
Preferred
Preferable IT background to understand complexities on the program
IT background preferred to understand program complexities
Benefits
Medical/Dental/Vision/Life Insurance
Long-term/Short-term Disability
Health and Dependent Care Reimbursement Accounts
Insurance (Accident, Critical Illness, Hospital Indemnity, Legal)
401(k) plan and contributions dependent on salary level
Paid holidays plus Paid Time Off
Company
Infosys Consulting
Infosys Consulting is a global management consulting firm helping some of the world’s most recognizable brands transform and innovate.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Qiu YE
Vice President Strategic Partnerships
Abdoul Anane Raimi
SCM Enterprise Resources Planning Partner (Consulting)
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