System/Equipment Validation Consultant

  • Lieu : Region of Antwerp
  • Type de contrat : Contrat à durée indeterminée
  • Débute le : 20 novembre 2019

Descriptif de fonction

Validation

Supports the project leader in coordinating the project team to achieve the defined project deliverables in relation to validation:

  • Lists together with the project leader and project engineers which validation activities need to take place and in what sequence.
  • Clarifies the overall project validation strategy to the entire project team.
  • Provides a continuous overview of the status of all validation activities and advises the project leader in relation to impact on project timeline.
  • Continuously follows up the predefined validation strategy and adjusts / escalates if needed.
    Writes and manages the VPP/VPR together with the project lead.
  • Watches over good validation practices (verification, validation master plan, change management, …) and the quality of the different deliverables.
  • Facilitates general validation activities (system risk assessment, cGMP-review). Point of contact related to validation in the project.
  • Coaches the project engineers related to verification/validation/CRF/QRM in the project.
  • Bridges between Engineering, Site Compliance, SME, System Owner throughout the project.
  • Clarifies the overall project validation strategy during internal and external project audits.

Scheduling

Supports the project leader in coordinating the project team to achieve the defined project time line:

  • Assist the project lead to compose, consolidate and update a timeline with different milestones, which must be endorsed by the team.
  • Develop and maintain accurate and complete detailed project schedule file in MS Project. Monitor continuously the project schedule file for integrity and completeness.
  • Keep the project team informed regarding the progress of all project tasks and activities and provide input for the management communication & reporting.
  • Alert the project team and Project Management of problems/conflicts relating to the execution of project tasks and activities.
  • Assist the project lead to define and evaluate project risks and to propose a mitigation plan. Document this process in the Project Risk Management document.

Compétences

  • structured
  • pro-active
  • good communication skills
  • quality mindset
  • detail oriented
  • planning skills

Expériences

Not looking for a technical profile but (for example) a person coming from quality with validation documents experience

  • Minimum 3-5 years’ experience in similar position (Validation in Engineering environmental, not labo)
  • Bachelor or equal by experience
  • Experience as a team member within projects.
  • Risk assessments, establish schedules/planning’s, project coordination experience
  • Dutch mandatory (spoken and written)

We are Not looking for computer validation, QC validation, method validation, cleaning validation, product validation, component validation. But System/Equipment Validation.

Avantages

Evolia is continuously growing and tends to hire highly motivated professionals in order to cover more geographical and industrial fields.
You will receive a permanent contract with competitive salary supplemented with attractive fringe benefits such as communication allowance, representation allowance, mobile, internet@home, hospitalization and group insurances.
20 holidays and 12 compensatory days an access to continuous training.

retour

POSTULER

remplissez le formulaire ci-dessous

Joindre votre CV
Joindre une lettre de motivation

retour