Senior Consultant–Computer System Validation-Life Sciences

Senior Consultant–Computer System Validation-Life Sciences Responsibilities

• Create, review, and approve validation deliverables
• Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure compliance in each release /iteration
• Work 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

• 5+ 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 (21 CFR Part 11, GxP, GAMP
  5)
• Experience creating, reviewing and approving validation deliverables
• Knowledge of risk management processes
• Thorough knowledge in compliance and validation concepts
• Proven ability to support multiple projects, responding quickly to changing situations in complex environments
• Preferable IT background to understand program complexities
• 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 unable to provide immigration sponsorship at this time)

• Strong understanding of pharmaceutical compliance regulations and validation concepts
• Experience with Agile and Waterfall methodologies
• Familiarity with tools like Service Now, 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

Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits:

• 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

Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.