Introduction

For our client we are looking to recruit a Validation Coordinator.

Organization

  • You are the link between Qualification and Validation and will 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.

Function

  • You will define, coordinate and guide the overall qualification & validation strategy & processes in line with project specifications in cooperation with the project team, internal & external stakeholders.
  • You ensure oversight of the qualification (IQ, OQ, PQ) and validation (PPQ, CV, PV) activities.
  • You are responsible for writing, reviewing and approving validation documents (Risk Assessment, PQ Protocol, PQ Report,…).
  • You are responsible for coordination of execution activities.
  • You are in charge of implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation).
  • You will implement adequate validation strategy in compliance with FDA, EMEA and International quality standards.
  • You will assureg inspection readiness – regarding Validation
  • You are responsible for smooth handover from PPQ/Process Validation to production (Training, SOPs etc.).
  • You will ensure assistance with requirements of Equivalence Reports, Equipment Family Reports, etc.

Requirements

  • You have obtained a university degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
  • You are an expert in the field of quality/validation activities & control tests, cGMP and EMA/FDA.
  • You have a good understanding of good practices in biopharmaceuticals
  • You have experience in a pharmaceutical production environment, process validation, equipment validation.
  • You 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.
  • You will use a risk-based approach for problem solving and prioritization of tasks.
  • You are in charge of blowing a quality and compliance mindset through the validation activities.
  • You have strong communication, organizational and influencing skills to work transversely.
  • You are a good team player in order to succeed in the validation project.
  • You speak and write fluent English, Dutch and/or French
  • You are able to work independently with minimal supervision and schedule tasks in time so the project can be delivered on time.

Offer

  • You will join an international group with the possibility to develop yourself professionally.
  • You will have the possibility to work on projects for the most renowned companies.
  • You can count on a competitive salary package.
  • Duration: +/- 12 months

Application

Stéphanie Sissokho
bcb@burdock.com
+32 3 650 09 25