LS CSV Consultant Business Consulting
LS CSV Consultant Business Consulting
Posted on :
30-09-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 89000 - 119000
Vacancy
1 Vacancy
Posted on :
30-09-2025
Job Description
Consultant 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 Consultant level who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain.
Responsibilities:
Required Skills & Experience
Along with competitive pay as a full-time Infosys employee you are also eligible for the following benefits :-
About Us
Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills expertise and ideas from our innovation ecosystem.
EEO
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. 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.
We are looking for smart self-driven high-energy people with intellectual curiosity and passion for excellence; specifically we are looking for candidates at Consultant level 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 clients 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
- 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 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.
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 Us
Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills expertise and ideas from our innovation ecosystem.
EEO
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. 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.
Required Experience:
Contract
Employment Type
Full Time
Key Skills
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