Deputy General Manager of Indonesian Factory

Job Responsibilities:

1.Be responsible for the company’s work of quality management to ensure the achievement of product quality, production, and business goals.

2.According to overseas market regulations, be responsible for establishing and improving the quality management system, keeping abreast of international regulatory guidelines, regularly tracking and updating information, and providing decision support.

3.Be responsible for supervising the formulation of corresponding quality standards, analytical methods, batch production and packaging records, analytical method validation and qualification , effectively controlling the key points of production process inspection.

4.Be responsible for the management of quality activities in overseas regions, including but not limited to: deviations related to product quality, OOS/OOT, on-site audits and qualification confirmation of changing suppliers, quality agreements with material suppliers, and annual product quality reviews.

5.Be responsible for assisting and supervising overseas regulatory compliance, including document support, registration applications, etc.

6.Be responsible for product release, such as packaging material audit, transportation and storage of products for market sales, complaints and recalls of products, assistance in the investigation of adverse reactions, and stability study tracking.

7.Organize self-inspections and external audit inspections, closely collaborate with other departments (R&D, production, sales), conduct training, and enhance the team’s quality awareness.

1、负责公司质量管理工作，确保产品质量、生产、经营目标的实现。

2、根据海外市场法规要求，负责建立和完善质量管理体系，关注国际法规指南，并定期跟踪和信息更新，提供决策支持；

3、负责监督相应的质量标准、分析方法、批生产及包装记录、分析方法验证、确认与验证的制订，有效控制生产过程检验的关键点；

4、负责海外区域质量活动的管理，但不限于：产品质量相关的偏差、OOS/OOT、变更供应商的现场审计及资质确认、物料供应商的质量协议、产品年度质量回顾；

5、负责协助和监督海外法规合规性，包括文件支持、注册申报等；

6、负责产品放行，如包材审核、产品上市销售的运输及储存、投诉及召回、不良反应的协助调查以及稳定性研究跟踪等；

7、组织自检及外部审计检查工作，与其它部门（研发、生产、销售）密切协作，开展培训并提升团队质量意识。

Job Requirements:

1.Master’s degree or above in pharmacy, pharmaceutical engineering, or related fields; with over 8 years of experience in international projects related to APIs or formulations; overseas or international pharmaceutical quality management experience is preferred.

2.Familiar with domestic and overseas regulatory requirements; possess experience in EU and FDA registration and certification; experience with authorized person in charge of quality is preferred.

3.Excellent written and spoken English skills.

4.Strong sense of responsibility, excellent leadership skills, and good abilities in organization and management, team collaboration, communication and coordination, and planning and overall coordination.

1、硕士及以上学历，药学、制药工程等相关专业，8年以上原料药或制剂国际化项目工作经验，有海外或国际制药企业质量管理经验优先考虑；

2、熟悉国内外法规要求，具备欧盟、FDA注册及认证经验，有质量负责人授权人经验优先；

3、优秀的英语书面及口语表达能力；

4、责任心强，优秀的领导力，具备良好的组织管理、团队协作、沟通协调和计划统筹能力。