Consultant–Computer System Validation-Life Sciences

Job Description 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
• 3 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 Required Skills & Experience
• 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.

EEO/About Us Benefits Along  with competitive pay, as a full-time Infosys employee you are also eligible for the following 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 About UsInfosys Consulting is a next-generation consulting partner that bridges strategy and execution. With an AI-first mindset, deep industry knowledge, and the combined strengths of business and technology consulting, it helps enterprises turn bold vision into tangible outcomes, faster, smarter, and osys Consulting is helping some of the world’s most recognizable brands transform and innovate.

Our consultants are industry experts that lead complex change agendas driven by disruptive technology. With offices in 20 countries and backed by the power of the global Infosys brand, our teams help the C-suite navigate today’s digital landscape to win market share and create shareholder value for lasting competitive advantage.

EEOInfosys 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.

Work Location Indianapolis, IN, New York, NY, Somerset, NJCountryUSAState / Region / Province Indiana, New Jersey, New YorkCompanyITL USA Interest Group Infosys Limited Salary Min
84706

Salary Max
102941

Domain Life Sciences Skillset Process |Consulting processes|Technology Consulting process

Job Role Associate - Business Consulting: 155670