北京招聘Quality Head

Quality Head

百奥泰生物制药股份有限公司

公司规模：500-1000人
公司性质：合资
公司行业：制药/生物工程

职位信息

发布日期：2021-01-13
工作地点：广州-黄埔区
招聘人数：1人
工作经验：10年以上经验
学历要求：硕士
语言要求：英语
职位月薪：30-150万/年
职位类别：生物工程/生物制药药品生产/质量管理

职位描述

1、Implement and maintain a high standard quality assurance procedure according to current ICH guidance including China, EU and US GMP regulations. Ensure the compliance of GCP, GMP and other GxP regulatory been always met during the clinical trial, commercial manufacturing and post marketing；

2、Monitor all production and QC test process, perform necessary on-site inspections and batch records reviews to make sure all the manufacturing and QC tests meet the predefined process specification and compliance requirements for data integrity prior to the final release of the product；

3、Lead and monitor the deviation investigations, CAPAs, risk management, self- inspections, change controls, and other quality activities. Prepare and lead all regulatory audit/inspection. Be ready to address all quality related issues and take the responsibility of corrective actions and continuous improvement of the performance of quality system within the company；

4、Review and approve the quality system procedures and documentations which covering the life cycle of drug product, from clinical trials, commercial production and post-marketing monitoring；

5、Prepare the regulatory audits and inspections according to product submission progress and other triggers, responsible for corrective actions and continuous improvement of QA procedures；

6、Conduct and lead the investigations, CAPAs, deviations and Quality Risk Management and other activities during the GxP operations. Responsible for the other quality related tasks assigned to Quality Head by management team as per urgent needs or company strategy；

7、Ensure the implementation of effective business processes, procedures and practices in alignment with regulatory expectations and company policies for data integrity through its lifecycle, including GxP computer systems, hybrid systems and manual/paper systems；

8、The Job Title will be assigned by company management according to candidates experience and capability.

任职要求：

1、Graduate Degree (or above) in Pharmaceutical related majors including pharmaceutical sciences, medicines, biochemistry, biological sciences, etc；

2、Minimum 12 years’ working experience in Pharmaceutical industry, 8 years’ experience in Quality assurance of GMP or GxP environment. Experience of sterile manufacturing quality management is a plus；

3、Familiar with quality assurance procedures according to Chinese cGMP, EU/US GMP, GxP, GCP, ChP, EP and USP, and other applicable international guideline such as ISPE, PDA, ICH, etc；

4、Good oral and written English required, must be able to read English protocols/reports, articles, etc.

5、Overseas working experience is a plus.

职能类别：生物工程/生物制药药品生产/质量管理

关键字：质量生物制药

公司介绍

百奥泰生物制药股份有限公司（股票代码：688177）秉承“创新只为生命”的理念，致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病以及其它危及人类生命或健康的重大疾病。公司已推动五款候选药物进入后期临床试验，其中格乐立（阿达木单抗）已在中国获批用于治疗类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病和葡萄膜炎。此外，公司另有多款主攻肿瘤和自身免疫性疾病的候选药物处于不同的临床开发阶段。公司始终以患者的福祉作为首要核心价值，通过创新研发为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问公司官网或关注我们的微信公众号“百奥泰”。
Bio-Thera？Solutions, Ltd.a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next-generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials, one of which, QLETLI, a biosimilar to？Humira？(adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis,？Crohn's disease or uveitis in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.

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