應屆畢業(yè)生
碩士
最近更新
1130人關注Position Description:
1. Establish and improve the whole chain quality assurance system of clinical trials to ensure compliance with international (FDA, EMA,TGA,ICH, etc.) and domestic (NMPA) regulations.
2. Organize and manage the whole chain inspection, supervision, quality control and CAPA of clinical trials.
3. Guide, review and approve standard operating procedures, rules and regulations.
4. Be responsible for the establishment and improvement of training system and professional assessment of clinical trial related posts.
5. Be responsible for the daily management, performance appraisal, technical guidance and training of the quality assurance and training department.
6. To ensure the implementation of the quality control plan of the clinical project and the on-site verification by the regulatory authorities of various countries.
7.To implement other tasks assigned by line manager timely.
Qualifications:
1.Master degree, major in Medical, Pharmacy or Pharmacology.
2.At least 15 years working experience in similar positions in large international or domestic pharmaceutical enterprises and CRO companies, and similar position experience in a third-party inspection company is preferred.
3.Rich experience in international reporting quality system construction, training, inspection and certification, and familiar with various regulations and guiding principles related to ICH / GCP and FDA / NMPA/EMA/TGA clinical trials.
4.Strong leadership, judgment, communication and innovation skills.Good English listening, speaking and writing skills.
注：聯(lián)系我時，請說是在江蘇人才網上看到的。
求職提示：用人單位發(fā)布虛假招聘信息，或以任何名義向求職者收取財物（如體檢費、置裝費、押金、服裝費、培訓費、身份證、畢業(yè)證等），均涉嫌違法，請求職者務必提高警惕。
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制藥·生物工程
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21-50人
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公司性質未知
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建鄴區(qū)嘉陵江東街18號3棟711室
