Brabant Walloon – Contracting Our partner is currently looking for a CMC Quality Solutions Specialist. Our partner is an international pharmaceutical company. 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 Additionally, the CMC Quality Solutions Specialist will represent the CMC Quality Lead team when assigned to projects and initiatives. For commercial products it can also include a support role for: 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 You hold a bachelor's or a master's degree in a scientific domain. 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 language verbally and in reading & writing. Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Background knowledge of the pharmaceutical industry from a business and technical perspective. Must be able to work autonomously for the assigned activities with limited supervision. Must be skilled and experienced in operating across cultures and in a multi-cultural environment. Must be able to independently analyze data and information to draw conclusions and make effective decisions. Must have the ability and agility to adapt to different type of products, tasks and Quality Leads in a collaborative mindset. Must be able to identify and suggest harmonization and synergies opportunities to improve ways of working across global products. Must be able to deliver presentations or reports adapted to the audience. Must possess good interpersonal, verbal, and written communication skills. Must have ability to identify risks and propose corrective actions within areas of expertise. Experience in GMP audits and inspections Project management skills would be an asset. Experience in Data Integrity assessment would be an ass... Synergy, Expertise, Presentations, Pharmaceuticals, Execution, GMP, Maintenance, Health System, Business, Audit, Data integrity, Shipping, Manufacturing, Biopharmaceuticals, Asset, Corrective Actions, Validation, Mitigation, Project Management, Projects, Inspection, Pharmaceuticals, Practicality, Regulation, Recalls, Writing, Risk Management, Data analysis, Metric, Self-confidence, Product QA, Agility, Reporting, Quality Control, Knowledgeable, Writing Skills, Product Quality, Change Control, Renewals, Quality assurance, Product Launches, Science, 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 carrièretips op StepStone.be!
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