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R&D Quality Manager - Pharma
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Pharmaceutical organization, based in Bern Switzerland.
Our client is a Pharmaceutical company focused on vaccines.
Lead the Quality / Compliance activities during the development and product transfer from R&D to internal/external sites.
- Core Team Member of Projects and Quality liaison for Project from inception through launch.
- Review and approve CMC and non CMC related documents, including product specification, batch documentation, test method, analytical validation report, method transfer, equipment qualification and calibration related documents, process and product transfer protocol and reports and packaging documentation.
- Support clinical supplies activities, including providing formal approval and release for clinical supplies, registration samples and consumer test supplies.
- Lead and oversee Change Control, Deviation, and CAPAs for R&D projects.
- Quality oversight of Pilot, Lab, and Clinical Supply facilities, including compliance responsibilities.
- Manage Heath Authorities and internal audits at local R&D sites and follow up on the appropriateness and completeness of corrective action plans.
- Support and/or lead GMP training program for R&D and ensure training practices are in compliance with the current standards.
- Working knowledge of applicable GMP and Regulatory Affairs regulations and guidelines
- Experience working in global and multidisciplinary environments
- Must be IT systems literate (MS Word, Excel, & Power Point) and be familiar with audit tracking systems (e.g., Trackwise) and regulatory submission management submissions
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.