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

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