LS Senior Consultant CSV Business Consulting
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Job Location:
Bridgewater, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days 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 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.
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 a next-generation consulting partner that bridges strategy and execution. With an AI-first mindset deep industry knowledge and the combined strengths of business and technology consulting it helps enterprises turn bold vision into tangible outcomes faster smarter and at scale.
Infosys Consulting is helping some of the worlds most recognizable brands transform and innovate. Our consultants are industry experts that lead complex change agendas driven by disruptive technology. With offices in 20 countries and backed by the power of the global Infosys brand our teams help the C-suite navigate todays digital landscape to win market share and create shareholder value for lasting competitive advantage.
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:
Senior IC
Key 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
