Validation Coordinator

Belgium  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

As the Validation Coordinator, you will be accountable to coordinate validation activities in collaboration with Quality Assurance, Production Technical Services Quality Control and Experts.
Your Responsibilities
  • You are responsible for the coordination of the validation of projects in Primary or Secondary Technical R&D GMP Manufacturing ' site.
  • You ensure correct and state of the art Validation approaches, be responsible, with the coaching of your Manager or a colleague, to establish the Validation Plan and be accountable for all GMP 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.
  • You are responsible for writing, reviewing and approving validation documents (Risk Assessment, Process Qualification Protocol, Process Qualification Report, etc.).
  • You are responsible for coordination of Process Qualification execution activities.
  • You are responsible for the implementation of the validation guideline and SOPs for the processes & equipment (Validation Life-Cycle process, Qualifications, Process Validation, etc.).
  • You are responsible for ensuring, during the design and validation steps, (until the end of consistency lots) for the facility project, writing, an independent review and first approval of validation documentation.
  • You participate to perform the writing of the facility submission files for the projects.
  • You participate, for validation sections, in external authorities' inspections (EMEA, FDA, WHO…) with the coaching of your Manager.
  • You participate in the implementation of adequate validation strategy in compliance with FDA, EMEA and International quality standards.


Basic Qualifications
  • Master's degree in Biology, Biochemistry, Chemical Engineering, Bio-Engineering, Pharmacy, or other relevant Science discipline.
  • At least 1-2 years' experience in aseptic processing or vaccine production including knowledge of the scale up principles, quality control tests, production technologies and Good Manufacturing Practices.
  • This individual should be familiarized with GMP environment and in validation activities.
  • French & English are a MUST.


Preferred Qualifications
  • Knowledge in Process Qualification (PQ) validation and GMP.
  • Experience in a matrix organization,.
  • Strong communication, organizational and influencing skills to work transversely.
  • Experience of working with cross-functional teams of diverse roles and profiles.


Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
Start date
01/2020
Duration
perm
From
Michael Bailey Associates
Published at
28.11.2019
Project ID:
1854206
Contract type
Permanent
To apply to this project you must log in.
Register