GDP QA Specialist – Upstream Supply Chain & 3PL

Astellas Pharma; Ciudad de México; Híbrido; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Astellas Pharma in Mexico City (Santa Fe) is seeking a GDP QA professional to oversee storage and distribution activities for upstream supply chain, ensuring GMP/GDP compliance and effective collaboration with SCM and 3PLs.

The role focuses on maintaining the QMS, handling nonconformances in TrackWise, approving changes, reviewing transportation studies, and auditing external partners; a BA/BS in Life Sciences and 3+ years in GMP/GDP QA with fluent business English are required.

Formación

• Fluent in business English (written, verbal, presentation)
• Ability to represent the company to external stakeholders
• Proven track record in QA, GMP/GDP areas, minimum 3 years' experience

Responsabilidades

• Supports the maintenance and enhancement of the global Astellas GDP QA Quality Management System (QMS) through cross functional team working, KPI monitoring and quality management reviews.
• Supports US upstream supply chain drug substance, drug product and materials release activities based on risk through Usage Decision in SAP S/4 with SCM and 3PLs.
• Ensures timely documentation of GDP related nonconformances in TrackWise with root cause analysis and corrective actions.
• Assesses and approves GDP related changes in TrackWise.
• Reviews and approves transportation study documents for new product launches and GDP changes.
• Oversees contracted 3PLs and Freight Forwarders to ensure their QMS is maintained and enhanced through CAPA and audits

Conocimientos

Fluent English

Stakeholder management

Quality mindset

Educación

BA/BS in Pharmacy or Life Sciences

Herramientas

TrackWise

Veeva

SAP

Descripción del empleo

Astellas Pharma in Mexico City (Santa Fe) is seeking a GDP QA professional to oversee storage and distribution activities for upstream supply chain, ensuring GMP/GDP compliance and effective collaboration with SCM and 3PLs.

The role focuses on maintaining the QMS, handling nonconformances in TrackWise, approving changes, reviewing transportation studies, and auditing external partners; a BA/BS in Life Sciences and 3+ years in GMP/GDP QA with fluent business English are required.