YOUR TASKS AND RESPONSIBILITIES

• Support routine operation management of QC Chemical Laboratory, ensure that the operation in QC Lab must be in compliance with the company standards and GMP requirements. Major responsibility includes but not limited to below business scopes:
• Responsible for the responsible area HSE performance; Support HSE activities followed internal & external regulations, procedures & SOPs.
• Manage the daily operation of assigned QC group to ensure the product supply meet the business needs and Site plan at the right quality, cost and speed. Contribute to products quality decision by means of proper activities of sampling, physical-chemical testing of all materials and products under compliance and safety.
• Ensure the team members complete the training in time and effectivity. Ensure all the procedures meet the GMP, CMS and related regulations in responsible areas. Ensure deviation initialized within 24h and finish evaluation and investigation sufficiently. Ensure change control follow approved workflow.
• Support QC lab to comply with national and internal regulations in all aspects via end-to-end quality control system oversight such as new product analytical method validation, qualification and transfer.
• Support to drive QC laboratory performance to ensure operation at highest possible laboratory and personnel usage rates at minimum cost and with minimum failures.
• Lead Laboratory analytical Equipment management, including new equipment purchase, URS, calibration, function test, qualification and maintenance. Conduct analytical equipment qualification and laboratory relevant computerized system validation.
• Ensure formal review and approval of all documentation, to include specification and test methods, records, CoA, method validation documentation, stability study.
• Ensure thorough analysis of failures (OOS and OOT) and implement corrective and preventive measures.
• Ensure appropriate training of staff. Provide coaching to QC team to ensure that they are qualified, achieve a high level of competence, and ensure that they are motivated and carry out their duties in a safe manner.
• Ensure lab relevant data Integrity, including daily / periodical audit trail review, retrospective review and QC staff DI mindset improvement etc.
• Ensure the team members complete the training in time and effectivity. Ensure all the procedures meet the GMP, CMS and related regulations in responsible areas. Ensure deviation initialized within 24h and finish evaluation and investigation sufficiently. Ensure change control follow approved workflow.
• Participate in QC optimization project of Global to promote the achievement of strategy objectives on QC lean efficient management.
• Continues to improve QC technical training management system to foster more comprehensive lab personnel and technical expert.

WHO YOU ARE

• Bachelor degree or above in Analytical chemistry or Pharmacy related majors 分析化学或药学相关专业，本科学历或以上

• At least 8 years’ experience in Quality Controls, prefer to have management experience至少8年QC工作经验，有管理经验者优先。
• An in-depth knowledge of chemistry, pharmaceutical analytical technologies and international GMP regulations.熟悉分析化学技术以及国际GMP法规
• Very good command of English (Spoke & Written)书面英语良好，口语良好
• Excellent in driving result in a changing environment.卓越的结果导向以应对不断变化的外部环境
• Strong team spirit, Excellent communication, problem-solving, planning and organization skills良好的团队合作精神，优秀的交流，问题处理，计划和组织能力
• Strong learning agility. Full of engagement.优秀的学习能力以及内驱力
• Good understanding of QC laboratory management.实验室管理的良好理解