上海招聘

Seeking a candidate with working experience (minimal 5-8 years) in establish a quality assurance and compliance system in Pharmaceutical R&D. The key responsibilities include (but not limited to):

• Build the documentations, records, and training programs
• Conduct internal cGMP training to scientific staff
• Design Change Control program, procedures, and training
• Coordinate the preparation and approval of internal SOPs, Protocols, and Procedures in the R&D function;
• Support QA issues related to functional technical development activities (formulation and analytical) and technical transfer to production
• Assure and review the contents of ANDA filing under cGMP requirements
• Conduct facility auditing and inspection according to the US FDA compliance when needed.
• To collaborate with QA-Production, QC, Production Facilities (API & Drug product), to ensure compliance with FDA current GMP guidance
• Candidate with experience in new drug development is a plus

普霖贝利生物医药研发（上海）有限公司创建于2009年9月。公司主要从事高端制剂的研究开发及制剂产品的注册，并同时与欧美知名药厂就药物研发进行战略合作共同研发药物。目前，科研主攻方向为化学药物的制剂研发，药物类型为抗心血管病、抗抑郁症、抗糖尿病、抗肿瘤及抗艾滋病药等。未来，公司将开展全方位的产品研发。

电子邮箱：hr_pb@prinburybiopharm.com