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Purification Validation Leader

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Job ID R0041313 Date posted Aug. 19, 2021 Location Lessines, Belgium

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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, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / experience:

  • 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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