Analyst Business Consulting Computer System Validation- Life SciencesWe 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 deliverablesDefine IT system development processes (build test deploy monitor) following Agile ways of working and ensure followed compliance in each release /IterationWorking experience on Agile/JIRA Confluence ALMAuthor major project validation deliverables as per clients standard operating proceduresReview and approve system lifecycle deliverables generated by project teamGuide project teams on applicable validation security and project management deliverablesContribute to internal and external audits assessments or inspectionsEscalate critical compliance findings risks or issues into appropriate client unitsPrepare management reports regarding compliance operations and progressBasic Skills & ExperienceGood 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 timeRequired Skills & ExperienceStrong 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 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:
IC
Analyst Business Consulting Computer System Validation- Life SciencesWe 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 ...
Analyst Business Consulting Computer System Validation- Life SciencesWe 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 deliverablesDefine IT system development processes (build test deploy monitor) following Agile ways of working and ensure followed compliance in each release /IterationWorking experience on Agile/JIRA Confluence ALMAuthor major project validation deliverables as per clients standard operating proceduresReview and approve system lifecycle deliverables generated by project teamGuide project teams on applicable validation security and project management deliverablesContribute to internal and external audits assessments or inspectionsEscalate critical compliance findings risks or issues into appropriate client unitsPrepare management reports regarding compliance operations and progressBasic Skills & ExperienceGood 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 timeRequired Skills & ExperienceStrong 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 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:
IC
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