Senior consultant, business consulting – computer validation specialist (life sciences)
infosys consulting's ls practice in mexico is seeking experienced management consultants with a background in computer system validation (csv) and compliance.
this is a senior consultant role.
location: monterrey, mexico city
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 ensuring compliance in each release/iteration.
work with agile/jira, confluence, alm.
author major project validation deliverables as per client's standard operating procedures.
review and approve system lifecycle deliverables generated by the 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.
required qualifications
overall experience of 8+ years.
in depth understanding of it csv – waterfall, agile and csa methodologies.
deep understanding of the pharmaceutical value chain.
ability to handle conversations with senior business and technology leaders from client teams.
desire to work as part of a cross-cultural team, with flexibility to support multiple time zones.
excellent customer service and ability to manage customer expectations.
excellent communication skills – strong verbal and written, with ability to adapt to different communication styles.
active listening, organizational, facilitation, and collaboration skills.
self-starter, quick learner, and proven ability to set priorities across multiple projects and drive for results.
proven experience working with internal and external clients, third-party vendors, and senior management to achieve project objectives.
experience in customer-acquiring roles and delivering impactful presentations to stakeholders.
effective communicator, must write, speak, and read english at high proficiency levels.
good to have
exposure to using ai/ml/automation creatively for client challenges.
strong 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 and deep industry knowledge, it helps enterprises turn bold vision into tangible outcomes, faster, smarter, and at scale.
infosys consulting helps some of the world's most recognizable brands transform and innovate.
with offices in 20 countries and backed by the global infosys brand, the 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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