Astellas Pharma

Global Serialization Technical Analyst

Ciudad de Mexico, Mexico · On-site
Salary not published
Posted 4 days ago

From Astellas Pharma's careers page

Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.

About the role

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks.

What they ask for vs. your profile

Must have

KPI tracking
Regulatory compliance
Troubleshooting
Communication

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Astellas Pharma

Global Serialization Technical Analyst

Ciudad de Mexico, Mexico · On-site
Salary not published
Posted 4 days ago

From Astellas Pharma's careers page

Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.

About the role

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

This position is based in Mexico City (Santa Fe area) and will require on-site work in a hybrid set up.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and Scope

The Global Serialization Technical Analyst serves as the technical owner and subject matter expert for Astellas' global Level 4 serialization platform and integrations with the associated partner ecosystems. The role is responsible for ensuring the reliable, compliant, and secure operation of serialization services, supporting global regulatory obligations through system administration, incident management, integrations, validation activities, and continuous platform enhancement across internal and external partners.

Role and Responsibilities

Serve as the technical owner for secure, reliable, and compliant integrations between the global Level 4 (L4) serialization platform and external partners, including CMOs, 3PLs, regulatory authorities, and trading partners.

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Collaborate closely with Serialisation Vendor support teams to manage incidents, service requests, and problem resolution activities, ensuring timely escalation and restoration of service for the L4 platform

Monitor, govern, and report service performance against established Service Level Agreements (SLAs) and Key Performance Indicators (KPIs), driving operational excellence and continuous service improvement.

Lead software lifecycle activities associated with new compliance requirements, system enhancements, and upgrades, including the authoring of impact assessments, test scripts and other GXP validation, documentation, and deployment in accordance with Astellas System Lifecycle and GxP standards.

Oversee the day-to-day administration and maintenance of the global serialization platform performed by our Serialisation Support vendor

Proactively identify, manage, and communicate system issues, risks, and service impacts, providing clear and timely updates to stakeholders during projects, enhancements, outages, and technical upgrades.

Act as the primary technical point of contact for production and quality environments, ensuring system availability, regulatory compliance, and business continuity for global serialization operations.

Essential Qualifications

Bachelor’s degree in Information Technology (IT) or Computer Science (CS).

Minimum of 5+ years demonstrated experience in the healthcare or pharma IT area

Excellent communication skills, both written and verbal English

Demonstrated experience working with business, non-technical business users

Able to support technical upgrade by conducting impact assessment, addressing any issues, support testing, and document changes per the System Life Cycle (SLC) processes in Astellas.

Ability to engage and manage critical problem and outage situations with high sense of urgency

Proven working knowledge in serialization system operation

Proven understanding of EMVS and/or DSCSA compliance

Benefits

Careers | Astellas

Why Astellas

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks.

People who act with unwavering integrity and are deeply committed to making a tangible impact.

Learn more at Astellas.com

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We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks.

What they ask for vs. your profile

Must have

KPI tracking
Regulatory compliance
Troubleshooting
Communication
Stakeholder management

What they ask for vs. your profile

Must have

KPI tracking
Regulatory compliance
Troubleshooting
Communication

Similar jobs

Global Serialization Operations SpecialistAmgenAdmin & operationsHyderabad, India · On-siteSalary not published5 weeks ago

Global Serialization Technical Analyst

About the role

What they ask for vs. your profile

Must have

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Global Serialization Technical Analyst

About the role

Essential Qualifications

Benefits

Why Astellas

Skills and Capabilities

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About

What they ask for vs. your profile

Must have

What they ask for vs. your profile

Must have

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Essential Qualifications

Benefits

Why Astellas

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