青岛招聘

职位描述：
? Manage QC department and all associated support functions, ensuring that all Microbiology, Chemical, Potency and Biochemical testing is performed according to the regulatory board requirements.
? Create and review internal procedures for conducting method transfers, validations and qualifications as well as comparability studies for adequacy with regulatory guidelines
? Ensure that the quality of drug substances and drug products meet all Regulatory commitments, manage the product stability testing program.
? Perform environmental monitoring (EM), cleaning verification / validation.
? Lead method transfer process effectively to deliver analytical methods from one site to another. Support technology transfer and regulatory submission with appropriate documentation.
? Maintain a current awareness and enforce applicable government regulatory, safety, occupational health, and environmental requirements.
? Create a budget including reagents, materials and equipment needed for method transfer.
? Hire, train, and provide career development.

Requirements:
? Advanced degree in sciences and more than 10 years of progressive responsibility in a GMP environment and at least 5 years managing a QC function, or comparable experience
? Knowledgeable in analytical techniques such as HPLC, GC, FTIR, UV-Vis, electrophoresis and other USP methods
? Hands-on experience with method development, validation and transfer in support of biopharmaceutical manufacturing
? Strong supervisory and project leadership skills and experience managing contract testing labs
? Excellent organizational skills and detail oriented. 举报 分享

成立于2004，泱林是医药研究，医疗器械和化工领域的专业咨询公司。