Validation Coordinator


Concernant cet emploi

  • Market: Sciences de la Vie & Santé
  • Branche: Pharmaceutique
  • Area of Expertise: Réglementation
  • Location: Brussel

Que faut-il?

  • hours per week: 40
  • Education level: Maîtrise universitaire
  • Closing date: samedi 13 février 2021

Concernant ce rôle

Define, coordinate and guide the overall qualification & validation strategy & processes in line with project specifications in cooperation with the project team, internal & external stakeholders.

To be the link between Qualification and Validation.

  • Ensure correct and state of the art Qualification/Validation approaches, to establish the Validation Plan and be accountable for all cGMP decisions taken during the Validation of the Investment project starting with the Design Qualification step and ending with the establishment of the Validation Summary report.
  • To ensure oversight of the qualification (IQ, OQ, PQ) and validation (PPQ, CV, PV) activities.
  • Responsible for writing, reviewing and approving validation documents (Risk Assessment, PQ Protocol, PQ Report,…).
  • Responsible for coordination of PQ execution activities.
  • Responsible for the implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation).
  • Responsible for the implementation of adequate validation strategy in compliance with FDA, EMEA and International quality standards.
  • Responsible for assuring inspection readiness – regarding Validation
  • Responsible for smooth handover from PPQ/Process Validation to production (Training, SOPs etc.)
  • Assistance with requirements of Equivalence Reports, Equipment Family Reports, etc.

Concernant vous

  • University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
  • Expert in the field of quality/validation activities & control tests, cGMP and EMA/FDA
  • Understanding of good practices in biopharmaceuticals
  • Experience in Pharmaceutical production environment, process validation, equipment validation
  • Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
  • Use a risk-based approach for problem solving and prioritization of tasks.
  • Blow a quality and compliance mindset through the validation activities.
  • Strong communication, organizational and influencing skills to work transversely.
  • Good team player in order to succeed in the validation project
  • You speak and write fluent English, Dutch and/or French
  • Must work independently with minimal supervision and schedule tasks in time so the project can be delivered on time.

Commencez votre candidature ici!

ll est facile et rapide de postuler chez Brunel. Envoyez-nous les informations suivantes :

  • CV récent ou profil LinkedIn
  • Lettre de motivation (optionnel)
  • Certificats (optionnel)
  • Références (optionnel)
Postulez dès maintenant

Des questions concernant le poste vacant?

Votre Talent Hunter,Elke Binst, est heureux de clarifier tout ce qui concerne ce poste vacant. En nous contactant, référez au ce numéro de vacature :

Talent Hunter

Elke Binst
Brunel Belgium Mechelen

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