What are the responsibilities and job description for the Senior Consultant- Computer System Validation- Life Sciences position at Infosys Consulting?
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 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
- 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 concept
- 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