Responsibilities:
1. Ensure that the Quality Management System (QMS) is effectively implemented and complies with all applicable domestic and international laws, regulations and standards
2. Contribute to managing and improving QMS
3. Support QMS-related actions including but not limited to
Preparing, reviewing and implementing quality assurance policies and procedures
Assisting in vendor quality management including planning/performing routine inspections and audits
Conducting Incident Investigation, Root Cause Analysis, and Impact assessment
Documenting quality assurance activities and creating/approving audit reports
Providing/Coordinating specific quality trainings to relevant employees
Qualification requirements:
1. Minimum 3 years of experience in QC and QA activities in the pharmaceutical, biochemical, or food industry
2. Bachelor degree or higher in science related field with laboratory experiences
3. The capacity for new experiences and challenges
4. Willingness to take increasing responsibilities while learning at the job
The ability to commit to the team's mission over individual interests
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崗位職責(zé):
1. 獨立有效的協(xié)助總裁處理綜合、協(xié)調(diào)各部門工作和處理日常事務(wù);
2. 負責(zé)總裁個人行程安排的管理;
3. 負責(zé)處理、安排并及時提醒總裁參加公司內(nèi)外各類商務(wù)、行政活動;
4. 負責(zé)拜訪總裁的客戶接待安排,客戶酒店、用餐、出行等的統(tǒng)籌安排;
5. 協(xié)助總裁協(xié)調(diào)公司內(nèi)外部工作協(xié)調(diào)與資源調(diào)配,確保項目高效率推動。
崗位要求:
1. 本科及以上學(xué)歷,985高校畢業(yè),生物醫(yī)藥,管理等相關(guān)專業(yè);
2. 2年以上總裁助理工作經(jīng)驗
3. 職業(yè)方向比較明確,為人誠信、務(wù)實,注重細節(jié),責(zé)任心強,執(zhí)行力強;
4. 英語聽說讀寫熟練,熟練使用辦公軟件
5. 時間觀念強,抗壓能力強;
6. 具備優(yōu)秀的思維邏輯及溝通協(xié)調(diào)能力、良好的原則性和靈活性;
7. 形象氣質(zhì)良好,熟悉商務(wù)禮儀,言談舉止得體。
Primary Responsibilities:
? Provide preclinical safety expertise and strategy for pre-clinical and clinical development programs from pre-clinical drug candidate selection to IND enabling and clinical trials
? Apply a broad understanding of toxicology, pharmacology, DMPK and regulatory sciences to design all types of toxicology studies required to support drug development of biopharmaceuticals
? Ensure that the preclinical safety plan is aligned with the clinical development plan and regulatory guidelines (ICH, FDA, GLP, etc.)
? Serve as Preclinical Safety team leader for multiple programs and contribute to the program’s goals and deliverables
? Identify and manage contract research laboratories (CRO) for preclinical safety studies; review reports; ensure they are using systems and processes in compliance with all relevant regulatory standards
? Write and review documents for INDs / regulatory section submissions; represent the company as the pre-clinical toxicology expert before regulatory authorities
? Serve as a subject matter expert to provide input for due diligence of potential external partnership programs
Qualifications:
? 10+ years of combined toxicology, drug development and regulatory experience in a biotech, biopharmaceutical or CRO setting
? Extensive knowledge and expertise with in vitro and in vivo toxicology study conduct and reporting
? Familiar with applicable regulatory guidelines; prior experience with regulatory agency interactions is preferred
? Proven leadership and management skills, including the ability to interact effectively with CRO personnel and internal/external experts for the conduct of toxicology studies
? Good communication and technical writing skills in English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts
Education:
? Ph.D. or equivalent in Toxicology or closely related field
? Toxicology board certification is a plus
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