Specific Duties, Activities, and Responsibilities:

• Provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure, validations, batch disposition, and qualification activities.
• Advise and provide support to other area Quality Assurance. The Quality Assurance position is essential for maintaining GMP compliance and providing support during preparation for inspections.
• Ensure regular presence in operational areas to monitor GMP programs and quality systems.
• Work with support teams and external partners to resolve or provide advice on product related issues (e.g., intro company issues, complaints investigation, etc.).
•  Be able to effectively review or approve documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls and engineering documents).
• Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.
• Follow various EHS management procedures and fulfill the work safety responsibilities.

Position Requirements:

• Bachelor’s degree or above, major in pharmaceuticals, chemistry or related science.
• Strong oral and written communication and interpersonal skills.
• Strong decision making and problem-solving skills.
• Demonstrate knowledge and understanding of manufacturing process and quality systems.
• Capable of listening, speaking, reading and writing in English.

职位申请请发送简历至 Recruiter.China@catalent.com