上海招聘

1. Objectives of the position

The Administrative Assistant is responsible for the coordination of all C.T. Distribution activities required at the China Depot, from the preparation of the upcoming receipts until the tracking of the final deliveries at the Sites, including coordination of additional stickering and returns for destruction from Sites.

2. Key responsibilities

· Main point of contact at China Depot for :

o Key client China Affiliate

o Partner CRO (CRA, CTA,…)

o ELECTS CT Distribution (EU, US, AP Distribution Buyer Planners and Distribution Material Coordinators)

o ELECTS QA

o INDY Product Delivery (Clinical Supply Coordinators, Demand Forecasters, Commercial Product Material Coordinators, Date Management Coordinators)

o Brokers, Couriers, Vendors of Commercial Products

· Partnering with the clients and with C.T. Distribution to understand delivery schedules and priorities

· Escalate to ELECTS C.T. Distribution and QA any discrepancy/gap/issue for any distribution activities

· Notify ELECTS C.T. Distribution and QA about any change in China Regulatory Requirements, identify gaps in Process/Procedures/Tools

· Proactively identifying ways to improve day-to-day activities and practices. Support efforts to improve productivity, efficiency, product quality and reduction of risk

· Review SOPs and Checklists as required

· Participate in the review of Process Flows and DCPR (Detailed Collaboration Partner Requirements)

· Participate in Audit preparation

· Creation of checklists and documentation files for batch receipt, additional stickering, shipping orders

· Coordination of importation/exportation of the batches before reception at the Depot with the help of the China Depot Import group

· Obtain Import License, coordinate customs clearance with broker/courier

· Validate feasibility to receive material at the China Depot by ensuring resources/storage area are available for the reception based upon quantity/volume/type of reception

· Partnering with China Depot Quality in order to give them the priorities, track the completion of QA activities and provide support for the investigations Quality would request

· Coordination of investigations related to customer distribution complaints, internal deviations, temperature excursion during shipments, temperature excursion at the warehouse

· Create CTMSRC and Proforma Invoices

· Creation of orders in CT-WIN system for non IVRS/IWRS managed material

· Confirmation of the orders in CT-WIN for all orders

· Ensuring all country specific requirements are met before shipping to the Hubs, Depots and Sites

· Ensuring all site specific requirements are met before shipping to sites

· Coordination of the shipments to the other Hubs (EU – AP – US), to other Depots and to Chinese Sites, including the import/export document preparation (Certificate of Origin, Notification of Site Readiness, Proforma Invoice, Clinical Trial Shipment Readiness confirmation form,…)

· Partnering with China Depot Operations (Warehouse operators) to provide them with the information and documentation they need to execute the orders (including the operational checklists and file documentation) and to give them the priorities as well as the requirements specific to the orders (Site & Country specific requirements)

· Select best method for shipment and consolidate shipments to Sites

· Partnering with the couriers and brokers to ensure meeting of timelines and priorities, and reception of information for the required investigations

· Coordination of the pick-up by the courier and tracking until delivery

· Coordination of post-delivery activities, tracking of shipments until their destination (including Proof of Delivery, Fit For Use determination and Acknowledgement of receipt)

· Read and analyse temperature devices

· Coordinate returns of insulated shippers as needed

· Coordination of Samples (as required)

· Coordination of the additional stickering activities (expiry extension stickering or additional stickering of Non-Modified Commercial drugs)

· Coordination of the returns for destruction from Sites with Sites, Courier and CRAs

· Coordination of the returns for redistribution

· Update of different tracking tools (Planning Reception, Site Specific Requirements, Planning Stickering, Chrono, Returns for Destruction,…)

· Scan and store documentation in the collaboration site

· Filing and archiving of files (shipping, batch, returns for destruction, additional stickering, returns for redistribution:

· Support the creation of Monthly Invoices based on tracking tools

· Provide CRAs/Lilly Affiliate with reports as needed

· Coordination of destruction activities for material expired, rejected or unused

· Review of the inventory system and tracking spreadsheets to ensure thorough completion and accuracy

· Track near-to-expire or expired products

· Ensure weekly inventory snapshot is stored in the collaboration for BCP purposes

· Creation of monthly metrics to measure results compared to key performance indicators

3. Competences and Experience Requirements

· Must be knowledgeable on how to apply GMPs in a clinical trial environment and review and follow procedures applicable to the CT business. In addition, individual training plans must be kept up to date

· Experience in Import and Export

· Knowledge of distribution and understanding of global shipping requirements, including country-specific requirements

· Demonstrated exemplary teamwork/interpersonal skills

· Strong organization and self-management skills

· Ability to use and apply multiple computer applications

· Ability to manage multiple tasks and respond to change

· Effective written and verbal communication skills in multi-cultural settings

· High initiative, flexible and positive attitude

· High degree of accuracy with work and attentive to details

· Ability to proactively identify problems and work toward a solution

· Demonstrated knowledge of cGMPs and experience in a highly regulated environment Customer and process focused

· Must speak fluent English

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 ****************