北京招聘

职位描述：
Major Duties and Responsibilities
? Direct all GXP compliance program in related to the manufacturing activities.
? Oversee all commercial and development product release to ensure all GXP compliances are met.
? Review and approve master batch records, executed batch records, QC release and stability and process validations.
? Provide oversight of production of drug substances and drug products.
? Manage product release and disposition according to current regulatory guidance and cGMP compliance.
? Prepare and/or review/approve investigations, deviations, CAPA, change controls, batch record release, protocols, SOPs and any other reports as needed.
? Review CMC documents including, but not limited to, protocols, amendments and reports for adequacy and compliance.
? Audit and oversee work performed by contractors to ensure meeting compliance.
? Provide support, guidance and training to Research and Development, Production and QC teams.
? Develop and execute an audit plan and coordinate the cGMP compliance audits.
? Evaluate significance of audits findings and coordinate the findings responses with the contractors.
? Coordinate the inspection program and interact directly with regulatory inspectors.
? Ensure compliance with regulatory agencies by coordinating audits, training programs, data and document review and analysis.
? Participate as a liaison during relevant negotiations and/or inspections.
? Write and review SOPs and related documents.
? Assist with preparations for FDA and other compliance audits.
? Maintain current knowledge of cGMP/GLP regulations and company policy and procedures.
? Write and review SOP and Quality Agreements for the QA department.
? Support Annual Product Review.

Experience and/or Educational Requirements
? MS or PhD in Chemistry, or related field.
? Minimum of 10 years of QA/QC and/or auditing experiences in a pharmaceutical environment or equivalent with pharmaceutical sponsored clinical research, including PAI experiences.
? Extensive knowledge of cGMP regulations, ICH guidelines and international compliance for CMC.
? Excellent communication, organizational, interpersonal and computer skills.
? Ability to identify compliance issues, communicate issues to others and identify resolutions effectively.
? Management experience required.
? Thorough understanding of FDA expectations on GXP compliances.
? Knowledge of product recall is a plus.
? Capable of communicating in English is a plus.
? Willing to travel internationally. 举报 分享

绿叶制药是致力于创新药物的研发、生产和销售的国际化制药公司。绿叶制药在中国、美国和欧洲设有研发中心，拥有40个中国在研药物和10多个海外在研药物，在中枢神经和肿瘤领域已有多个创新制剂和创新药在欧美市场开展注册及临床研究。绿叶制药在微球、脂质体、透皮释药等先进药物递送技术领域达到国际先进水平，并在创新化合物和抗体、细胞、基因治疗以及智能制剂等领域进行了积极布局和开发。

绿叶制药深度布局全球供应链体系，已在全球建有7大生产基地，超过30条生产线，并建立了与国际接轨的GMP质量管理和控制体系。绿叶制药现有30余个上市产品，产品覆盖抗肿瘤、中枢神经系统、心血管、消化及代谢等规模***及增长速度最快的治疗领域；业务遍及全球80多个国家和地区，其中包括中国、美国、欧洲、日本等全球主要医药市场，以及高速增长的各地新兴市场。