Global Quality Lead Solutions Partner - Braine l'Alleud, België - Randstad

Beschrijving

We are looking for a Global Quality Lead Solutions Partner for one of our clients based in Braine-l'Alleud.

Don't hesitate to contact me : - Life Sciences Wallonie.

Project contract until end December 2024.

key responsibilities

This position closely collaborate with the Global Quality Lead (GQL) relative to Quality Assurance activities associated with the lifecycle management for a product, including technical transfer and validation, submissions/variations, launches, product improvements.

As Global Quality Lead Solutions Partner your main tasks will be:

• Product Change Control Committee preparation and change controls follow-up, quality review for change proposals related to the product life cycle management.

• Maintenance and lifecycle management of QA product flows

• Audits and Inspection readiness

• Product metrics

• Review of Annual Stability Plan

• SOPs and other control documents writing, review and approval as needed

• Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))

• Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)

• Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed

• Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed

• Product Impact Assessment as required to support deviations and investigations.

• Interface with Medical Information Team and prepare answers to their requests and questions related to the product in scope.

Additionally, the Global Quality Lead Support will represent the Global Quality Lead team when assigned to projects and initiatives.

qualifications

We expect this requirements for the position of Global Quality Lead Solutions Partner :