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
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