Contracting – Brabant Wallon As a 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. More specifically, provide quality support for qualification and validation activities related to Clinical Manufacturing activities like facilities cleaning processes, viable and non-viable environmental monitoring, equipment and system qualification/validation 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 the company development activities and products. Support Change Control 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 Master's degree in Sciences Fluency in French and English 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 are an asset. 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 Ability to work autonomously for the assigned activities with limited supervision 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 Jefferson Wells offers you a permanent contra... GMP, Science, DS, Protocols, Business, Spot checks, Manufacturing, Improvement process, Biopharmaceuticals, Asset, Validation, Laboratory Work, Quality assurance, Inspection, Investigations, Regulation, Pharmaceuticals, Practicality, System Support, Quality systems, Development project, Risk Management, VOS, Health & Safety, Quality Support, Evaluation, Product Development, KPI, Product Quality, Change Control, Quality assurance Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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