成都招聘

岗位目标简述 JOB PURPOSE:

该职位负责公司生产运营供应商质量审计和管理。为亿腾的生产基地提供战略质量计划，以确保供应商管理程序、法规质量和合规标准及指导得以实施并持续下去，审核/评估并批准供应商。

The position is responsible for the supplier quality audit and management. Provides strategic quality programs to Edding Pharma(EDP) manufacture sites to ensure that supplier management procedures, regulatory quality and compliance standards and guidance are implemented and are sustainable, audit/evaluate and approve supplier accordingly.

监控供应商的质量和合规活动，确保所有的质量活动都符合cGMP、法规标准和亿腾的政策，以确保海外运输服务的质量是可持续的。

Monitors quality and compliance activities in suppliers to ensure that all quality activities operations are in compliance with cGMP’s, Regulatory standards and Edding Pharm Policy, to make sure the quality of materials and oversea transportation service for Vancocin are sustainable.

作为调查和解决所有供应商质量问题的主要联系人，并与相关利益相关者就这些问题进行交流。

Is the main point of contact for the investigation and resolution of all supplier quality issues handling and for interacting with the relevant stakeholders on such issues.

与供应商保持良好的关系。

Keep good relationship with suppliers

主要职责KEY ACCOUNTABILITIES:

1. 确保亿腾集团生产运营GMP供应商活动的适当执行，包括

Ensures appropriate implementation supplier activities for EDP operation GMP supplier, includes:

· 执行供应商审计以确认供应商的质量和符合性活动确保所有的质量活动操作符合cGMP的法规标准和亿腾制药的方针。

Perform supplier audits to make sure quality and compliance activities in suppliers to ensure that all quality activities operations are in compliance with cGMP’s, Regulatory standards and Edding Pharm Policy

· 供应商评估和批准以确信货物安全运到亿腾制药，避免交叉污染或混淆

Supplier evaluation and approval to make sure goods shipped to EDP safety, avoid cross contamination or mix-up.

· 定期的对供应商绩效审核

Supplier performance review regularly.

· 在供应商提出重要变更时，及时和其他部门合作，分析供应商的变更对提供物料的质量影响，并和供应商进行沟通解决因变更导致的相关监管部门通报或备案流程

Cooperates with other departments to assess the quality impaction of the changes from suppliers, when the magnificent changes are reported by suppliers, and communicate with suppliers to resolve the notification or registration process for authorities due to the changes.

· 供应商质量问题处理，如供应商投诉…

Supplier quality issue handling, like supplier compliant…

2. 确保有和供应商的质量协议

Ensures Quality Agreements with supplier are in place.

3. 确保从供应商到亿腾制药的货物的储存和运输符合要求

Ensures goods are stored and transported in accordance with requirements from supplier to EDP.

4. 确保供应商质量符合性问题被跟踪和解决

Ensures supplier quality compliance issues are tracked and resolved.

5. 决定对退回的亿腾制药货物的批准或拒收

Takes the decision to approve or reject returned EDP goods.

6. 确保对同事的适当的供应商培训和再培训

Ensures appropriate training and refresh training on supplier to colleagues.

7. 监督供应商客诉的适合处理并跟进根本原因分析和预防纠偏计划

Monitors appropriate handling of supplier complaints and follow-up on root cause analysis and CAPA plan

8. 负责为供应商管理建立持续管理符合性关键绩效指标

Responsible to establish the Ongoing Management compliance key performance indicators for supplier management.

9. 可能被分配的其他工作

Other jobs which may be assigned

主要要求 KEY REQUIREMENTS:

教育背景 Education:

本科学历，制药、化学、生物、微生物、生物化学、工程等相关专业。

Bachelor degree in Pharmacy, Chemistry, Biology, Microbiology, Biochemistry, Engineering or similar related disciplines.

工作经验与技能 Experience & knowledge:

具备较强的供应商审计经验和技能，包括国内外供应商的审计。

Strong ability to audit supplier， including domestic and oversea supplier.

在制药行业的质量保证或其他相关的质量职能部门，需要至少5年以上的工作经验。

A minimum of 5 years previous experience is required in positions of increasing responsibility within Quality Assurance or other relevant quality functions within the pharmaceutical industry.

良好的英文沟通能力。

Good communication skills in English.

良好的沟通和人际交往能力，能够引导团队。

Strong communication and interpersonal skills to guide groups.

适应工作优先级，以应对复杂或快速变化的环境。

Adaptable to work priorities in response to complex or rapidly changing environment.

用有限的资源推动目标的达成。

Deliver results with limited resources.

能够定义、评估、推荐和实施法规遵从领域的改进机会。

Ability to define, evaluate, recommend and implement improvement opportunities in the regulatory compliance areas

核心能力 Core competencies:

• 质量保证或其他制药产业的质量相关职能。

Quality Assurance or other relevant quality functions within the pharmaceutical industry

• 熟悉国内和国际制药行业的法律和法规

Familiar with Chinese and international pharmaceutical industry laws and regulations

• 有物流和供应运作经验。

Experience in logistics & supply operation, desirable

亿腾医药是一家综合性的医药公司。我们的愿景是凭借我们经市场验证的完整价值链能力，成为专注于抗感染、心血管疾病及呼吸系统三个核心治疗领域“放眼全球、服务中国”的医药公司。

一方面，我们致力于不断引入全球优质医药资源，拥有具有国际竞争力的生产设施和全球供应链，采用国际标准的运营管理，且领导团队具备国际视野；另一方面，经过近二十年的不断探索，我们凭借对中国市场的深刻洞见，构建起规模化的高效商业化平台和高标准的本土生产基地，并取得优异的运营表现。

我们相信“放眼全球、服务中国”的双轮驱动模式，能帮助我们更好地服务中国市场，为患者持续提供优质的全球医疗产品和服务。