Brabant Wallon Contracting As Quality Solutions Specialist you will provide support to a group of CMC Quality Lead professionals relative to Quality Assurance activities associated with the lifecycle management for products commercially available or in late stage development. Product Change Control Committee preparation and change controls follow up Maintenance and lifecycle management of QA product flows Audits and Inspection anticipation and 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 Quality Complaint Committee preparation and complaints oversight Product recall and product escalation meeting preparation Annual report (i.e., reporting of change controls to Health authorities) Yearly Biological Product Report Minimum of 3 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience in GMP in Quality, Manufacturing or Quality Control would be an asset Fluent and confident use of English Knowledge in several areas of the global pharmaceuticals industry, including the interpretation and practical application of applicable regulations. Autonomy and adaptability Skilled and experienced in operating across cultures and in a multi cultural environment Understanding of CMC Regulatory requirements Jefferson Wells offers you a permanent contra... Pharmaceuticals, Execution, GMP, Maintenance, Health System, Audit, Shipping, Manufacturing, Biopharmaceuticals, Asset, Validation, Mitigation, Quality assurance, Inspection, Development, Pharmaceuticals, Practicality, Regulation, Recalls, Writing, Risk Management, Metric, Self confidence, Product QA, Adaptability, Reporting, Quality Control, Product Quality, Change Control, Renewals, Quality assurance, Product Launches, CMC 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 carrieretips op StepStone.be! Original job ad is published on StepStone.be Set up a Jobagent at StepStone now and find your dream job! https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be! La version originale de cette offre d''emploi est disponible sur stepstone.be Creez maintenant votre Job Agent sur StepStone et trouvez le job de vos rves ! https://bit.ly/2jPYsZC Trouvez des job