苏州招聘

for a Europe pharmaceutical manufacturing company

Responsibilities:

Before Start Up

• Prepare and review all documents to be submitted to the Chinese SFDA authorities
• Establish and maintain an excellent relationship with all relevant authorities
• Ensure the project design compliance with EU, US, and Chinese GMP requirements
• Establish quality management system
• Approve all quality related SOPs
• Organize GMP related training
• Finish QC related design
• According to headquarter technical requirements, establish analysis method
• Technical report to HQ
• Overall organize the project qualification and validation

After Start Up

• Prepares and reviews all documents to be submitted to the Chinese authorities
• Organize the GMP audit (internal or external)
• Keep efficiency and effective QA system
• Coordinate with HQ to improve QA system
• Response for customer complaint investigation and CAPA implementation
• Organize GMP related training
• New products application of GMP
• Perform a regular quality meeting
• Technical report to headquarter
• To ensure that all starting materials, packaging materials, intermediate, bulk and finished products meet the registration requirements and specifications
• To ensure that the batch records are reviewed before product release
• To ensure that all necessary testing is carried out
• Approve specifications, sampling methods, testing methods and other quality management procedures

汇杰(Resourceful)于2004年成立，总部位于苏州，是一家专业的招聘咨询服务公司，专注于为企业提供中高级专业人才招聘解决方案，在工业制造、教育、医药医疗等行业是汇杰的强项。服务覆盖中国大陆地区主要城市。