Senior Consultant-Computer System Validation-Life Sciences
Senior Consultant, Business Consulting - Computer System Validation- Life Sciences
We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates at Senior Consultants levels who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain.
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
Basic Skills & Experience
• 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.
• Preferable IT background to understand complexities on the program.
• Collaborative attitude.
• Location: New York, New Jersey, Indianapolis
• Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time
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Required Skills & Experience
• 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.
• IT background preferred to understand program complexities.
• Excellent communication and collaboration skills.
Perks and Benefits
Health and Wellness
- Health Insurance
- Life Insurance
- HSA
- Short-Term Disability
Parental Benefits
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- On-site/Nearby Childcare
Work Flexibility
Office Life and Perks
- Commuter Benefits Program
Vacation and Time Off
- Paid Vacation
- Paid Holidays
- Personal/Sick Days
- Sabbatical
Financial and Retirement
- 401(K)
- Relocation Assistance
Professional Development
- Learning and Development Stipend
Diversity and Inclusion
- Employee Resource Groups (ERG)