Senior Consultant–Computer System Validation-Life Sciences jobs in United States
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Infosys · 1 day ago

Senior Consultant–Computer System Validation-Life Sciences

Infosys is a global leader in next-generation digital services and consulting. They are seeking a Senior Consultant experienced in IT Computerized System Validation within the Life Sciences domain to create and approve validation deliverables, define IT system development processes, and guide project teams on compliance and security requirements.

ConsultingInformation ServicesInformation TechnologyIT ManagementSoftware
badNo H1Bnote

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

Computerized System ValidationPharmaceutical compliance regulationsAgile methodologiesWaterfall methodologiesRisk management processesValidation deliverablesIT backgroundCommunicationCollaboration skills

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
Collaborative attitude
Strong understanding of pharmaceutical compliance regulations and validation concepts
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 is a technology company that offers consulting, outsourcing, cloud infrastructure, program management, and software services.

Funding

Current Stage
Public Company
Total Funding
$200M
Key Investors
ChrysCapital
2012-12-12IPO
2008-07-10Post Ipo Equity· $200M

Leadership Team

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Salil Parekh
Chief Executive Officer and Managing Director
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Anant Adya
Executive Vice President
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Company data provided by crunchbase