Senior Specialist, Quality Control - pMDI Project

About the role

AstraZeneca is looking for a Senior Specialist, Quality Control for its leading-edge project: the new pMDI manufacturing facility in China. The role provides quality support to achieve the project milestones and ensures GMP compliance throughout the design, construction, start-up and validation of the Qingdao capital project.

Key responsibilities

• Provide quality support to achieve the pMDI project milestones.
• Ensure GMP compliance during the design, construction, start-up and validation (full life cycle) of the Qingdao capital project.
• Ensure GMP compliance and operational effectiveness of the validation program, including facility, equipment and utility qualifications, computer system validation, cleaning validation and process validation.
• Take part in cross-functional work with colleagues in Operations and Quality, internally and externally.
• Mentor, train and develop QC and other engineering and operations staff and interns, and contribute to GMP training activities.
• Supervise and oversee contractor and intern activities as required.

Required profile

• Good understanding of Chinese legislation, cGMPs, validation and quality systems.
• Ability to influence stakeholders and partners and to solve complex quality control issues.
• Effective communication with colleagues.