This is a role as the quality control specialist in the leading edge project of new pMDI manufacturing facility in China.
The role incumbent will
• Provide Quality support to achieve the pMDI project milestones.
• Responsible for ensuring compliance with GMP requirements during the design, construction,
start-up, validation (entire life-cycle) of Qingdao capital project initiative.
• Ensuring GMP compliance and operational effectiveness of the validation program (facility, equipment, utility qualifications; computer system validation, cleaning validation or process validation).
• Participate in cross functional interaction with both internal and external colleagues in Operations and Quality
• Mentor, train, and develop QC and other engineering / operations staff and interns in relevant technical subjects and is a key contributor to GMP training activities.
• Supervise and Oversight contractors and intern activities as required.
The incumbent has good understanding of china legislation, cGMPs, Validation and Quality Systems.
The incumbent is capable of influencing stakeholders and partners and be able to effectively solve complex quality control issues and actively communicates with colleagues.