Analyst–Computer System Validation-Life Sciences

hace 3 horas

Monterrey, Nuevo León, México Itl Mexico A tiempo completo
Analyst, 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 Analyst 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

• 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

• 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 Mexico 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.
 

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 world's 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.

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