LSSenior Consultant-CSV Business Consulting

Indianapolis, IN - USA

Monthly Salary: $ 130000 - 177000

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 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

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

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.

For candidates based out of NYNJ states estimated annual compensation will be $130000 to $177000

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:

Senior IC

Senior Consultant Business Consulting Computer System Validation- Life SciencesWe 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 Computeriz...