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.

其他信息

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