Purification Validation Leader

☞ Takeda

Ver: 160

Día de actualización: 26-11-2025

Ubicación: Lessines Hainaut

Categoría: Seguro de Calidad / Control de Calidad

Industria: Financial Services Biotechnology Pharmaceuticals

Posición: Associate

Tipo de empleo: Full-time

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Contenido de trabajo

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Job Description

The Validation Leader manages resources, drives continuous improvement, standardization and coordinates qualification / validation activities linked to his/her part of the business.

He/She is a validation expert and coordinates the preparation and implementation of the validation documentation required to assure the proper development of a project. He/She supports regulatory submissions.

The Validation Leader implements and maintains current the Global Master Facility Validation Plan (FVMP) for his/her parts to assure that all equipment are validated and in an accurate validation state.

Main Accountabilities
  • Resource management :
  • Hiring/Coordination of internal/contractors,
  • Ensures the adequate participation of his validation team within project meetings (Coreteam, Planning Session…),
  • Participate to Capacity management and Steering Committee meetings,
  • Maintain load plan to anticipate future resources needs
  • Contribution to continuous improvement and International standardization for topics related to his/her part of the business including :
  • Participation of the global discussions forums
  • Participation to Community of Practices meetings
  • Alignment of local practices to Divisional Procedures
  • Define the validation strategy of small, mid size and big projects within the plant and ensure their completeness,
  • Management and development of team members,
  • Defend validation topics related to his/her part of the business during Regulatory Inspection
  • Assure the ability to meet the Department goals in respect to Quality, Finances, Fulfillment and EHS.
Education / Experience

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
  • BS Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
  • 5 years in Validation/Quality system with efficient technical skills.
Core Competencies / Skills / Leadership Behaviors
  • Familiar with Quality Management and GxP Regulations
  • Project and people management experience
  • Excellent communication skills, fluent in english (written and spoken)
  • Familiar with Quality Management and GxP Regulations
  • Knowledge of Validation Methodologies
  • Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
  • Knowledge of the manufacturing processes
  • Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
  • Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines.
Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Plazo: 10-01-2026

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