长沙招聘

职位描述：
Essential Duties and Responsibilities.
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
? Actively manage supplier quality related activities:
             Lead new supplier visit and/or audit as required, follow up audit findings
Maintain existing suppliers, and improve supplier quality performance
Provide supplier performance data trends for KPI Review
Issue SCAR whenever necessary
? Review and approve project documentation including protocols and reports for quality and scientific content.
? Develop new or revised QMS procedures and documentation. Review and provide input to regional procedures as required.
? Lead or participate in assessments and/or audits to ensure compliance with quality system requirements, including Pharmaceutical Partners, Corporate Assessments, Regulatory Agencies, etc.
? Prepare and conduct training on quality system processes. Provide technical consulting in area of expertise to groups within and outside of Medical Products R&D (China).
Summary
Assist QA Manager with the development, implementation and maintenance of quality systems in support of the Medical Products R&D(China) in order to ensure compliance with Corporate and regulatory agency requirements and standards.
Work with cross-functional departments to manage supplier development, qualificaiton & maintenance activities for New Product Development and life cycle management projects.
Qualifications.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
1. Knowledge in the areas of pharmaceutical product, medical device or container closure development, supplier quality management
2. Knowledge of FDA (21 CFR Part 210 and 211), ICH, EMEA and CFDA regulations and guidelines for therapeutics

Education and/or Experience.
 Include the education and/or experience that is necessary to perform the job satisfactorily.
1. Bachelor degree or above with a pharmaceutical or medical device background or similar
2. A minimum of 5-year experience in a quality/regulatory environment
3. Experience with supplier management
4. Excellent team work and communication skills 举报 分享

百特国际有限公司提供肾科与医院关键产品的广泛组合，包括居家透析、急重症透析和中心透析产品；无菌静脉输液；输注系统与设备；肠外营养；生物外科产品与麻醉；以及药房自动化、软件和服务。公司凭借全球布局，以及其产品与服务的必需性，在提升新兴与发达国家市场医疗可及性方面发挥至关重要的作用。百特在全球的五万名员工，秉承公司在医疗创新领域的深厚积淀，持续推动未来的医疗创新，更好地满足患者的医疗需求。

Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.