上海招聘

I. Position Overview:

Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans.

II. Essential Functions:

Daily supervision of quality assurance associates includes direction of daily activities as necessary, resolution of issues with quality assurance and internal, external clients.

• Prepare associates performance reviews for assigned associates. Provide performance reviews in both oral and written form to associates.

• Review and release of batch documentation.

• Review and approval of quality events such as deviations, investigations, document control and change control.

• Quality assurance review and approval of validation documents (IQ/OQ/PQ).

• Quality assurance review of construction/facilities maintenance activities plans.

• Author quality assurance SOPs.

• Identify deviations/investigations during manufacturing or packaging process and provide direction as to appropriate course of action.

• Lead or assist in GMP training of associates.

• Train new associates as required.

• Perform packaging audits.

• Meet deadlines according to agreed timeframes and communicate adjustments as needed.

• Clear understanding of related SOPs, cGMPs necessary to accomplish daily tasks.

• Mentor and develop direct reports.

• Adhere to company policies.

• Attend assigned meetings.

III. Position Requirements:

Education and Experience: Bachelor’s degree in a scientific discipline with 5+ years of Quality Assurance experience in a GMP environment. LEAN, Sig Sigma or ASQ certification preferred.

Knowledge/Skills Requirements:

• Excellent verbal and written communication skills.
• Lead by example according to Catalent's values and culture
• Highly organized and attentive to detail.
• Ability to lead teams and influence stakeholders.
• Recognizes and address unmet needs within department.

• Identify and drive quality improvement initiatives.

• Collaborate with peers and demonstrate leadership capabilities in a matrix environment.

Catalent Overview

We are a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development to patient.
With over 85 years of experience in the industry, Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. We became a publicly traded company (NYSE: CTLT) in 2014 and have grown to become a vibrant community of more than 11,000 employees supporting over 7000 products for over 1000 customers all around the world. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.
Currently, Catalent has invested in two facilities in Shanghai, China, located in Waigaoqiao FTZ and Pudong Tangzhen, is near by China’s Zhangjiang Pharma Valley area. The two clinical supply centers will work together to provide a comprehensive range of clinical supply services to clients in China, Asia Pacific and around the world.

Catalent. More products. Better treatments. Reliably supplied.™

For more information please visit our website ****************


康泰伦特概览

我们是临床研发和给药技术的全球领导者，从药物研发，商业化生产到全球服务，我们的技术和服务贯穿于产品的整个生命周期，配方前期研究到生产供应的每一个阶段，我们都能提供完善的方案服务，助力提供更好的产品疗效，让每个人的生活更健康，更精彩。
康泰伦特拥有85年的行业服务经验，每年支持我们的合作伙伴推出200+新产品，超过700亿的年产量。康泰伦特是一家朝气蓬勃的公司于2014年上市并发展成为在全球拥有11,000名雇员，为全球1000多家客户提供7000多款产品。在康泰伦特我们的核心价值观是患者***，在全世界范围内，运用专业知识和先进技术和客户合作提高和改善患者生活。
目前，康泰伦特已在中国上海投资了两家临床供应中心，分别位于外高桥保税区和毗邻张江药谷的浦东唐镇，满足客户国内外临床试验的差异化需求。两家临床供应中心将共同协作为中国、亚太以及全球客户提供全面广泛的临床供应服务。

康泰伦特。更多的产品。更好的治疗。可靠地供应。™

获取更多信息请浏览公司官网 ****************