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, ALMAuthor 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 & Experience5 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 concept 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 :-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
