广州招聘

职位描述：
Job Description:
1. Assist QA Director to provide support Operations and R&D to ensure that products are developed, manufactured, tested and delivered according to established procedures, and that they meet all quality requirements.
2. -Organize and coordinate internal audit, external audit, inspection, customer visit （incase QA is involved）
-Perform gap analysis
-Raise quality alert to LGQ in case needed.
3.Involved in any GMP related topics in case of compliance risk is identified.
4.Supervise GMP Training (LSO), CAPA Oversight, DMS, LIMS, Trackwise Administrators
5.Supervise the Key quality systems management and the quality system team, support their daily work.
6.Continue to improve quality system
7.Ensure compliance with Lonza supplier qualification program to ensure that material and component vendors meet required standards of quality

Job requirement:
1. Bachelor degree or above;
2. 5+ years of experiences on related expertise
Very strong knowledge in GMP compliance for international standard (US and EMA)
Must have strong GMP background in API.
With good practice in customer relationship handle, GMP audit in B2B industry.
3. Experienced on quality assurance systems required for a GMP /ISO operation. Must be familiar with related domestic and international GMP requirements and practices.
4. Strong business acumen, with strategic thinking and good decisions quality
Ability to develop clear, actionable steps in support of business objectives.
Strong communication and interpersonal skill, a mature relationship builder.
Proactive, high level of commitment and accountability.
An effective team player. 举报 分享

关于龙沙
在龙沙，我们将技术创新与卓越生产及工艺完美结合，助力我们的客户在保健、防腐与保护领域实现他们的研发成果。

我们是全球制药、生物技术与特殊成分市场的优秀合作伙伴。 我们致力于疾病预防，并通过助力客户推出创新药物用以辅助治疗或治愈一系列的疾病，促进我们的世界更健康。同时，我们也提供广泛的微生物控制解决方案，共同营造和维护健康的环境。

1897年，龙沙诞生于瑞士的阿尔卑斯山脉地区，迄今拥有 120 个生产基地和办事处，遍布全球超过35个国家。 我们拥有约15,500名全职员工，由他们组成的高效团队及每一名员工都为我们的业务和所在地区及国家做出意义非凡的改变。2019 年，公司销售额达59亿瑞士法郎，核心业务的息税折旧摊销前利润（EBITDA）达16亿瑞士法郎。更多详情，请访问 *************。


About Lonza
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.
We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at ************* and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.