, Transfer, and Validation documentation. Ensure all data complies with cGMP, GDP, FDA, EMA, and ICH Guidelines through...
with the EMA review process concluded positively in September 2023. It is an exciting time in the company’s development...
Operations from Early Stage to Commercial Excellent understanding of FDA, EMA regulations and ICH guidelines Excellent...
reports, traceability matrices, and final qualification documentation packages. Support regulatory inspections (FDA, EMA...
reports. Perform risk-based commissioning and qualification activities in accordance with FDA, EMA, and internal quality...
, regulatory expectations (FDA/EMA/ICH), and quality systems. Excellent leadership, project management, and communication skills...
for energy efficiency, reliability, and compliance. Ensure designs comply with cGMP, ASME BPE, ISPE Baseline Guides, FDA, EMA...
preferred Solid knowledge of current good manufacturing practice and global regulatory expectations, including FDA and EMA...
standards. This includes, but is not limited to, ensuring site compliance with FDA, EMA and other cGMP regulations, overseeing...
-up and analytical method transfer Experience with equipment qualification Existing knowledge of FDA, USDA, EMA...