【泰州 Quality Head招聘】-猎头顾问泰州招聘信息-猎聘

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资深顾问(SC) · 苏州黑马方舟企业管理咨询有限公司

简历处理快

聊一聊

职位介绍: Main Responsibilities: 1. Be accountable for all quality activities (QS,QA,QC) of site, lead the entire quality team to drive sustainable quality compliance culture in the site; 2. To ensure the site to be inspection-ready and compliant with GMP of the applicable regulatory requirements (e.g., EDQM) and pharmacopoeia standards for the manufacturing and distribution of non-sterile GMP raw materials to the applicable pharmaceutical markets; 3. To lead the quality team members to establish and continuously improve the quality system incl. but not limited to CAPA, change control, document control, GMP training, OOS/OOT, customer complaint, supplier quality management, internal and external audit management etc.; 4. To provide strategic QA oversight and lead team members to deploy and maintain a robust GMP program to manage all aspects of the shop-floor quality operation, deviation / non-conformance investigation, quality release of materials and products, the Product Quality Reviews, contamination and pest controls etc; 5. To lead QC team to establish and improve the quality system of QC lab, and ensure the QC activities to achieve sustainable quality compliance in accordance with all applicable regulatory (GxP) requirements (e.g., EDQM) and registration files for all applicable markets; 6. To provide strong leadership/ coaching / training on all quality related matters and collaborate with all stakeholders to promote collaborative and sustainable quality compliance culture of the site; 7. To manage the budget and resources of quality department. Qualification: 1. At least bachelor degree in Chemistry, Chemical engineering, Pharmaceutical engineering or related; 2. Minimum 15 years of hands-on and progressive GMP experiences in quality system, Quality Control and quality product assurance of pharmaceutical company, at least 8 years of team management experiences; 3. With proven experience in the application and interpretation of cGMP requirements of various regulatory authorities/ guidelines (e.g., ICH, EU, US FDA, NMPA, etc.); 4. With proven experience in successfully hosting and responding to regulatory inspections; 5. With strong leadership, communication skills and conflict management skills; 6. Be hands-on, result-driven and reasonable; 7. Fluent English speaking.

其他信息: 语言要求：普通话 + 英语; 行业要求：制药

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