Manufacturing System Quality Partner
Contracting – Brabant Wallon
Your responsibilities:
Part of the Internal Bio & GT manufacturing Systems Quality Team, you will:
* Work closely with Clinical Manufacturing Teams to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
* Ensure adequate QA support for environmental monitoring, qualification, validation (including cleaning) and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas
* Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
* Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
* Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect development activities and products.
* Support Change Control, Deviation, Events, Investigations,… and perform the QA evaluation
* Ensure KPI (including extracts) are adequately maintained and Shared.
* Ensure Issued Copy document are following the issued copy and reconciliation process
Your profile:
* A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
* QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems is essential.
* Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
* Understands practical applications of GMP, compliance principles and theories including risk management
* Fluency in French & English
* Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments