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Senior Consultant, Business Consulting - Computer Validation Specialist (Life Sciences)...

Senior Consultant, Business Consulting - Computer Validation Specialist (Life Sciences)...

Infosys ConsultingLinares, MX
Hace 1 día
Descripción del trabajo

Senior Consultant, Business Consulting - CSV (Life Sciences) – Mexico

Infosys Consulting's LS Practice in Mexico is seeking experienced Management Consultants with a background Computer System Validation and compliance to join at a Senior Consultant Level.

Responsibilities :

  • In-depth knowledge of GxP, GAMP 5, 21 CFR Part 11, Annex 11
  • 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
  • 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

Location

  • Monterrey, Mexico City
  • Required Qualifications :

    The candidate is expected to demonstrate excellent core competence and experience in delivery of IT CSV projects following Waterfall and Agile methodology. The successful candidate shall possess :

  • Overall experience of 8+ years
  • In depth understanding of IT CSV- Waterfall, Agile and CSA methodologies
  • Deep understanding of pharmaceutical value chain
  • Ability to handle conversations with senior business and technology leaders from client teams
  • Has the desire to work as part of a cross-cultural team, including flexibility to support multiple time zones.
  • Excellent customer service with ability to manage customer expectations.
  • Excellent communicator with strong verbal and written skills
  • Ability to easily adapt to different communication and working styles.
  • Active Listener
  • Excellent organizational skills
  • Self-starter and quick learner
  • Proven ability to set priorities across multiple projects and drive for results.
  • Good attention to details
  • Strong time management skills
  • Excellent facilitation and collaboration skills
  • Work effectively with internal and external clients, third party vendors, and senior management in accomplishing project objectives.
  • Experience in customer-acquiring roles in developing and delivering impactful presentations to stakeholders.
  • Effective communicator, must be able to write, speak and read English at high proficiency levels.
  • Good to Have

  • Exposure to using AI / ML / Automation creatively for client challenges.
  • Must have excellent business acumen including analysis, critical reasoning, strategic thinking, data interpretation, and business problem solving ability.
  • Strong interpersonal, leadership and communication skills
  • ABOUT INFOSYS CONSULTING :

    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 world's 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 today's digital landscape to win market share and create shareholder value for lasting competitive advantage.

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    Senior Consultant • Linares, MX