LS/ Consultant CSV - Business Consulting
About The Position
Infosys Consulting is seeking a Consultant in Business Consulting focused on Computer System Validation (CSV) in the Life Sciences domain. The role is intended for experienced Senior Consultant-level candidates with professional experience in Life Sciences and IT computerized system validation. The consultant will create and review validation documentation, support compliant system development using Agile ways of working, guide project teams on validation and security requirements, contribute to audits and inspections, and report on compliance progress. The position is listed for New York, New Jersey, or Indianapolis. Applicants must be authorized to work for any U.S. employer without employer-based visa sponsorship; Infosys cannot provide immigration sponsorship for this role.
Requirements
- At least 3 years of professional experience in the Life Sciences industry, working for a consulting services organization and/or in industry.
- Good understanding of pharmaceutical compliance regulations, including 21 CFR Part 11, GxP, and GAMP 5.
- Experience creating, reviewing, and approving validation deliverables.
- Knowledge of risk management processes.
- Thorough knowledge of compliance and validation concepts.
- Experience with Agile and Waterfall methodologies.
- Ability to support multiple projects and adapt quickly to changing situations in complex environments.
- Excellent communication and collaboration skills.
- Authorization to work for any employer in the United States without employer-based visa sponsorship.
Nice To Haves
- IT background to understand program complexities.
- Familiarity with tools such as ServiceNow, JIRA, Veeva, and HP ALM.
- Experience with Agile/JIRA, Confluence, and ALM.
Responsibilities
- Create, review, and approve validation deliverables.
- Define IT system development processes for building, testing, deploying, and monitoring systems using Agile practices, and ensure compliance in each release or iteration.
- Author major project validation deliverables according to client standard operating procedures.
- Review and approve system lifecycle deliverables produced by project teams.
- Guide project teams on applicable validation, security, and project management deliverables.
- Advise project teams on implementing compliance and security controls at appropriate stages of system development.
- Contribute to internal and external audits, assessments, or inspections.
- Escalate critical compliance findings, risks, or issues to appropriate client units.
- Prepare management reports on compliance operations and progress.
Benefits
- Medical, dental, vision, and life insurance.
- Long-term and short-term disability coverage.
- Health and dependent care reimbursement accounts.
- Accident, critical illness, hospital indemnity, and legal insurance.
- 401(k) plan and contributions dependent on salary level.
- Paid holidays and paid time off.
- Competitive pay.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
