上海招聘

  SUMMARY OF ESSENTIAL FUNCTIONS:  

Candidate must be flexible and have well-developed organizational skills and have the ability to interact with all levels  of management. 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 and in process control 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: 

• Establish, Maintain and Supervise Quality Management System across Sites 

• Direct quality team and have overall responsibilities for quality assurance, quality control. Must have a demonstrated track record of talent management; building bench strength and setting clear objectives for performance and accountability.

• Implement Global quality policies and standards, CSS network procedures at sites. 

• Responsible for the quality aspects associated with global quality systems. Responsible for compliance to global standards of cGMP.

• Drives process efficiencies and continuous improvements to product realization and release process

• Maintains contact with key customers about quality communications

• Monitor Sites Training Program for compliance with GMP’s and internal procedures.

• Monitor Sites Supplier Management Program, provides guidance and direction for compliance with global SQM policy

• Monitor Sites Deviation/ Change Control/ Complaint, involves in critical/major issues investigation and action plan. 

• Participates in IACP audits to sites if required

• Leads or assists with regulatory and customer audits of the facility as required

• Other duties as assigned by VP Quality                        

  

POSITION REQUIREMENTS:

    

Education: BS Degree in a Science or Pharmaceutical discipline  

  

Experience: Ten years of experience working in a chemical, pharmaceutical, food or relevant industry with at least Five years’ experience in QA/RA areas with progressive responsibilities. Experience in managing people, providing leadership, and implementing developmental plans for personnel.

  

  

Knowledge/Skills:

  

• Must have a demonstrable record of implementing and maintaining and total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operations and quality metrics.

• Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards.

• Experience in facilitating regulatory inspections.

• Strong understanding of the functional areas of manufacturing, sourcing, materials management and quality control.

• Understanding of QA/QC GMPs and in interpreting and enforcing regulatory requirements.

• Comprehensive knowledge of regulatory organizations and requirements

             

Supervises: Quality Assurance and Quality Control encompassing QMS

  

  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 judgment. Good negotiation and reasoning skills.

• Excellent written and verbal communications skills. Ability to easily learn and retain technical information.

• 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.

                

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