北京招聘

PURPOSE OF THE ROLE

Assess the level of quality and compliance of suppliers in China vs. applicable contractual agreements, company standards, regulatory requirements and business needs
Identify and alert the EQ-QA Management of business threats and risks
Support the stakeholders with risks management and CAPA plan establishment

MAIN TASKS & RESPONSIBILITIES
Timely schedule and execute audits as per approved EQ-QA Audit plan
Deliver audit findings to auditee's management in a constructive yet firm manner
Report in timely manner reliable assessment of the GxP quality compliance level of processes, tools, quality systems, and resources of suppliers
Issue reports in English according to the established EQ-QA standard
Alert immediately the Management of any critical or compromising audit finding in an expert manner
Support the stakeholder in the establishment of a technically sound CAPA plan, and to follow up on CAPA until completion and close-out of the audit
Produce reports on quality/trends/indicators on the basis of audit findings
Support the establishment and maintenance of compliant and efficient audit processes within EQ-QA


MANAGEMENT SUPPORT

Support the Management in completing the audit program
Participate and/or lead in the elaboration and generation of audit tools (e.g. templates, checklists, SOPs, working instructions)
Provide support in the field of technical expertise to other EQ-QA functions to achieve the departmental objectives

FUNCTIONAL KNOWLEDGE

Solid knowledge and experience of internal Quality Standards, and rules and regulation including but not limited to: Chinese GMP, EU GMP, US GMP, ICH Q7, WHO, GDP, as a must and an ISO certification is an asset
Knowledge and experience in the manufacturing of Pharmaceutical Drug Substances chemistry and/or pharmaceutical Drug Products forms, Storage/distribution and release of products
Ability in identifying risks to quality and business during auditing activities and to evaluate their magnitude and potential impact.
Current with the international quality and regulatory Standards, trends, rules and regulations
OTHER

This position requires traveling (ca. 50% of the time)
EDUCATION AND LANGUAGE

Life Science degree, Chemical Engineering, a Master or a PhD would be a plus
Chinese mother language
Fluency in English is a must
PROFESSIONAL SKILLS & EXPERIENCE
Minimum 10 years solid experience in pharmaceutical chemistry or manufacturing of pharmaceutical products.
A minimum of 5 years in auditing
Solid Quality Assurance understanding and experience in a regulated healthcare environment is a must
Demonstrated success records in independent auditing
PERSONAL SKILLS & COMPETENCES
Assertiveness and strong skills: ability to interact constructively with management and functions
Strong verbal and written communication skills,
Result-oriented
Excellent time management and organizational skills
Ability to maintain effectiveness when experiencing major changes in work tasks or work environment
High sense of confidentiality and ethics

Merck – Living Innovation
默克 – 创新引领生活

默克是一家全球领先的医药与化工公司，以创新和高科技优质产品闻名世界。

默克在全球66个国家与地区拥有约38,000名员工，致力于改善患者的生活质量，助力客户实现长远的成功和迎接全球化挑战。

默克旗下四大业务分支——默克雪兰诺、消费者健康、功能性材料和默克密理博——2012年总收入达112亿欧元。

默克是全球历史最悠久的医药与化工公司。自1668年起，默克就成为了创新、成功和负责任的企业家精神的代名词。默克家族作为公司的创始人至今仍持有默克大部分的股份。

我们是默克，正根正源，在全球拥有“默克”这一名称和品牌的所有权。唯一的例外是在美国和加拿大，我们使用“EMD”的名称。
Merck – Living Innovation

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors.
Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.
We generated total revenues of