QA OPS Consultant

Introduction Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and learning moments are key. We are very open and communicative go-getters who are keen on results and quality. To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing. Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry. Work is important; however, we also attach great value to a healthy dose of Triggered? Let's meet" Job Description The QA Engineer I – QA OPS is responsible to supportCartridge manufacturingandbatch release activities. Accountabilities (ongoing activities, tasks the role is responsible for): The function holder will be present on the operational shop floor. Quality oversight of cartridge materials handling (warehouse, handling of materials non conformities, qualification of new materials and changes to existing materials). Quality oversight on development and commercial cartridge manufacturing activities (Review of cartridge manufacturing batch records, handling of process non conformities, follow up of CAPA's, assessment of process change request, performance quality reviews and trending). Quality oversight on cartridge stability studies. Quality oversight on equipment qualification, changes to equipment, introduction of new equipment. Quality oversight on new product introduction. Product Batch Record Review and Batch Release Process. Creation of Certificate-templates for Cartridge Batch Release. Responsible for Cartridge Batch Disposition in our ERP system. Contribution in realization of the Quality & Operations goals & objectives. Participate in continuous improvement of existing processes and procedures related to Biocartis' cartridge manufacturing processes. Participate in audits performed by external parties. Profile Education & expertise: Bachelor level in science (biomedical/pharma/biochemical/biotechnology) is required or equivalent through experience. A Master's degree or PhD in bio-engineering, chemical engineering, biomedical science, industrial pharmacy would be an asset. At least 2 years of experience in the function of Quality Engineer, Quality Control Engineer or Production Engineer in an: IVD – Medical Device manufacturing environment or Pharma environment Or equivalent by experience You have expertise in IVD – Medical Device Manufacturing, ISO 13485 / FDA 21 CFR 820 and MDSAP. Technical / Theoretical knowledge: Applied knowledge of Good Documentation Practices / Good Manufacturing Practices. Good applied knowledge of procedures/work instructions in a strongly regulated industry (medical devices, pharma); Hands-on experience with a QMS system; Experience in participating in deviation investigations, determining root cause, and developing corrective action plans is an asset; Customer focused; Very accurately and have an eye for detail; Strong organization and prioritization skills, and able to adapt to changing priorities; Good analytical and conceptual thinking skills with the ability to solve key problems; Strong communicator, verbally and in writing; Able to work in team and influence others. Skills: Decision making skills from a quality / compliance perspective Positive mindset and drive Technical writing skills Presentation skills Offer Freelance or as consultant on our payroll Will you become one of us? Gross salary between €2300 & €3200 / month Net allowance with a maximum of €150 Company car + fuel card Mobile phone subscription Group and hospitalisation insurance 12 days extra off due to a 40-hour working week + 20 legal holidays Meal vouchers + eco vouchers Training opportunities Join a financially sound company and become part of a group of no fewer than 2,500 top colleagues We cannot wait to meet you Fill in the form below and maybe we will meet very soon