LS Principal CSV- Business Consulting
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Job Location:
Bridgewater, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
We are looking for smart self-driven high-energy people with intellectual curiosity and passion for excellence; specifically we are looking for candidates at Principal 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
7 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.
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.
Benefits
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 Consulting is the global management and technology consulting practice of Infosys a global leader in technology services and consulting. We combine the power of time-tested methodologies people-driven innovation and disruptive technology to enable leaders of the worlds top brands pursue a path of smart transformation. Together with our clients internal and external partners we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants:
Ability to design and implement end-to-end solutions at scale
A flat organization structure with direct access to our senior-most leaders
An entrepreneurial environment full of bright highly motivated consultants
Opportunities for motivated consultants to impact local communities
The ability to design your career and drive your professional learning and development
A truly global culture
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.
Required Experience:
Staff IC
Key Skills
- Business Development
- Classroom Experience
- Dayforce
- Go
- Cloud Computing
- AWS
- Teaching
- Administrative Experience
- Leadership Experience
- negotiation
- SAS
- Data Analysis Skills
About Company
Welcome to Infosys Careers for Experienced Professionals As a leading provider of next-generation consulting, technology and outsourcing solutions, we are dedicated to helping organizations in over 46 countries to renew their core and simultaneously innovate into new frontiers. Whilst ... View more
