Senior QA Engineer

Job Description   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 QA 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 Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.) • Provide Quality expertise to the project and later site. • Propose solution options to improve and/or resolve technical challenges. • Support development of GPQS, ECMS, GVLMS database and provide oversight and expertise. • Provide ownership of QMS including validation, change controls, deviations, and related infrastructure activities within the Qingdao Operations site. • Interface with engineering IT, QC, manufacturing, and technical functions on capital projects and proactively ensure GMP compliance during the design, construction and start up phases of the project. • Develop and drive necessary departmental process, documentation and training. Typical Accountabilities (per AZ framework and regulatory expectations)   • Conduct activities and interactions consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.

职位描述