北京招聘

Principal Accountabilities:  

1. Participate/lead calls to understand client needs and develop proposals and/or Statement of Work (SOW)
  2. Provide the following services (not all-inclusive list):

• Performance of audits and/or gap assessments and authoring of reports against Regulatory (FDA, Health Canada, EMEA, etc.) requirements. Audits and gap assessments context: Routine and For Cause Internal，Routine and For Cause External, Inspectional Readiness, Qualification of new suppliers etc.
• Development and delivery of training on various topics related to Quality System requirements.
• Assist with remediation efforts as required to include (but not limited to) project management, hands on technical support, and may include items such as: Development and Management of Master Corrective Action Plan (MCAP), Quality system design/re-design, Review of investigation reports and associated CAPAs and Effectiveness Checks, Coordination of deliverables associated with Regulatory commitments, Development of Regulatory updates etc.
• Develop/revise technical documentation including, but not limited to: SOPs/Work Instructions, Quality Manuals and Policies, Master Plans, Protocols and Reports (IQ, OQ, PQ, CSV, etc.)

  3. Comfort with Analytical Method Development Protocols/Reports is a plus
  4. Experience with pharmaceutical processes, techniques, and quality assurance expectations associated with a broad range of dosage forms such as Active Pharmaceutical Ingredients, Oral Solid Dose, Steriles.
  5. Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
  6. Maintain current knowledge of the shifting regulatory landscape and associated industry standards and best practices.

Required Skills and Qualifications:

• Bachelor’s Degree in Science (Chemistry, Biology, Microbiology, or STEM Engineering related field)
• Experience should be in Quality Assurance preferably working at a site supplying overseas markets, e.g. China, Australia, Japan, EU
• Having work experience with pharmaceutical manufacturing sites and/or Quality Control in addition to Quality Assurance is a plus.
• Proactive with strong communication and interpersonal skills both internally and in client facing situations
• Excellent verbal and written communication skills in English and Mandarin
• Comfortable providing support both on-site and virtually as required.
• Able to multi-task in a fast-paced work environment
• Should be proficient in using Microsoft Office Suite and/or standard software applications typically used in a corporate office environment.

NSF International成立于1944年，我们始终坚持和改善全球人类健康的使命。NSF International作为一个全球性公共健康组织，促进公共卫生领域的标准开发，并对食品、水、健康科学和消费品行业的产品提供检测和认证服务，以此来最-大程度地降低对人类健康的不利影响并保护环境。NSF International在全球175多个国家设有办事处，是泛美卫生组织/世界卫生组织（WHO）指定的食品安全、水质和室内环境的合作中心。

为了给中国地区的客户提供更加便捷的支持和服务，协助他们符合国际贸易进出口方面的安全、质量、诚信和监管要求，NSF International于2005年和2011年先后成立了中国地区的业务营运中心：上海禾邦认证有限公司（NSF Shanghai Co., Ltd.）和恩福（上海）检测技术有限公司（NSF Shanghai Testing Technology Company , NSF旗下获得了ISO/IEC 17025认可的实验室）。

我们热情期待你的加入！请将中英文简历（在邮件标题中注明申请职位）Email至邮箱chinahr@nsf.org，公司将提供完善的薪资福利和良好的发展机遇。