Senior Consultant-Computer System Validation-Life Sciences

Infosys LTD•Indianapolis, IN

60d•$130,000 - $177,000

About The Position

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.

Requirements

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
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.

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