Principal QA Engineer

Location： Qingdao Site

This is a role as the principal quality assurance engineer 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).
• Cross functional interaction with both internal and external colleagues in Operations and Quality to ensure full compliance with AZ standards and local regulations. 
• Design and lead the automation digital processes to support QA business.
• 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

The incumbent has expert level understanding of China legislation, cGMPs, Validation and Quality Systems, specifically deviations and change controls and maintains current knowledge of regulatory and industry trends.

The incumbent is capable of influencing stakeholders and partners and be able to effectively make decisions for quality assurance issues and actively communicates with colleagues.  

Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)

• Provide Quality expertise to the project and later site.
• Influence site management and propose solution options to improve and/or resolve technical challenges.
• Support development of GPQS, ECMS, GVLMS database and provide oversight and expertise.
• Provide oversight / 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.
• Develops and maintains technical competency and collaborates with counterparts in engineering, IT, QC, manufacturing and technical functions to provide Quality oversight in designated projects and activities.
• Supports quality assurance efforts for GMP related facility and equipment systems to ensure full GMP compliance.

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.

In addition, for Managers and Project Team Leaders:

• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Ethics and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness. 
• Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.