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Analyst–Computer System Validation-Life Sciences
Indeed
Full-time
Onsite
No experience limit
No degree limit
Calz. Sta. Cruz Cacalco 82, San Joaquín, Miguel Hidalgo, 11260 Ciudad de México, CDMX, Mexico
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Description

Summary: Seeking a self-driven, high-energy Analyst with intellectual curiosity and a passion for excellence in IT Computerized System Validation (CSV) within Life Sciences. Highlights: 1. Opportunity to create, review, and approve validation deliverables 2. Define IT system development processes following Agile methodologies 3. Guide project teams on validation, security, and project management **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.

Source:  indeed View original post
Juan García
Indeed · HR

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Indeed
Juan García
Indeed · HR
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