上海招聘

Job Title: Quality Specialist Reports To: Quality Manager, Shanghai
Department: Quality Assurance FLSA Status: Exempt


SUMMARY OF ESSENTIAL FUNCTIONS:

Candidate must be flexible and have well-developed organizational skills and have the ability to interact with all levels of personnel. Candidate must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. Candidate is responsible for assisting in managing the development, implementation and maintenance of quality assurance standards and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards.


SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

· Support activities of the Quality Manager
· Supports the Quality Risk Management program
· Supports Document Management as needed
· Monitor and track training for compliance with GMP’s and CSS procedures.
· Collects data, and identifies trends; report on key performance indicators
· Supports Quality Management Review
· Assure metrics, which reflect quality of product and service are maintained and reported.
· Supports the Training Program for GMP Training, Procedural based training, and other training need for performing tasks.
· Assist with customer audits of the facility as required.
· Assist in preparing the site for inspection by regulatory authorities.
· Participate in regulatory inspections as required.
· Develop new procedures, and review and update existing procedures.
· Represent QA on project teams and other internal forums.
· Use and extract information from the following systems: Documentum, TrackWise, and ComplianceWire
· Creation of customer presentations, GMP Statements, memos, and other customer enquiries as required.
· Work closely with peers on timely completion of Complaints and Deviations
· Support needs before, during, and after Regulatory Inspections
· Perform self-inspection and spot check to ensure operation compliance
· Support Validation activities as needed
· Collect environmental, water, and air samples as required. Communicate with contract laboratory performing analysis. Evaluate and report data.
· Assist with protocol design, setup, and execution.
· Metrology tasks for validation-equipment including performing verifications where necessary and organizing calibrations with the Maintenance Coordinator and/or external vendors, and maintaining organized calibration certificates and related documentation
· Maintain the Calibration Database for validation equipment
· Organize and maintain Operational Verification documentation
· Organize and maintain validation protocols
· Coordinate validation activities with Engineering, Project Management, and Operations group to ensure a quick turnaround.



POSITION REQUIREMENTS:

Education: BS Degree

Experience: 3 years or above of experience working in a pharmaceutical/device packaging industry with emphasis in the clinical space preferred. Licensed pharmacist preferred

Knowledge/Skills:

· Good mathematics skills, statistical software or application skills preferred
· Good written English is required
· Understanding of pharmaceutical procedures.
· Read and understand MSDS requirements and restrictions.
· Candidate must have the ability to work effectively under high pressure with multiple deadlines.
· Candidate must be detailed oriented with good oral and written communication skills and good interpersonal skills.
· Candidate must have computer skills with MS Office and capable of quickly learning other software including Documentum, TrackWise and ComplianceWire.


PHYSICAL/MENTAL REQUIREMENTS

· Mathematical and reasoning ability
· Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
· Ability to work effectively under extreme pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
· Overall about average intelligence, creative thinker with sound business judgement. Good negotiation and reasoning skills.
· Excellent written and verbal communications skills. Ability to easily learn and retain technical information. Must be fluent in both Chinese Mandarin and English
· Excellent problem solving skills, including innovative and creative solutions.
· Well organized with ability to handle multiple activities simultaneously.
· Self-starter with the ability to work with people at all levels within Catalent and within customer organizations.


WORK ENVIRONMENT

Individual’s primary workstation is located in the office area, where the noise level is low. Stressful conditions at times.

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