Location： Qingdao Site
This is a role as the quality assurance associate directin 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 fensuring compliance with GMP requirements during the design, construction, start-up, validation (entire life-cycle) of Qingdao capital project initiative.
● Ensuring GMP compliance operational effectiveness of the validation program (facility, equipment, utility qualifications; computer system validation, cleaning validation process validation).
● Cross functional interaction with both internal external colleagues in Operations Quality to ensure full compliance with AZ standards local regulations.
● Design lead the automation digital processes to support QA business.
● Mentor, train, develop QA other engineering / operations staff interns in relevant technical subjects is a key contributto GMP training activities.
● Supervise oversight contractors intern activities as required
The incumbent has expert level understanding of China legislation, cGMPs, Validation Quality Systems, specifically deviations change controls maintains current knowledge of regulatory industry trends.
The incumbent is capable of influencing stakeholders partners be able to effectively make decisions fquality assurance issues actively communicates with colleagues.
Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)
● Provide Quality expertise to the project later site.
● Influence site management propose solution options to improve and/resolve technical challenges.
● Support development of GPQS, ECMS, GVLMS database provide oversight expertise.
● Provide oversight / ownership of QMS including validation, change controls, deviations, related infrastructure activities within the Qingdao Operations site.
● Interface with engineering IT, QC, manufacturing technical functions on capital projects proactively ensure GMP compliance during the design, construction start up phases of the project.
● Develop drive necessary departmental process, documentation training.
● Develops maintains technical competency collaborates with counterparts in engineering, IT, QC, manufacturing technical functions to provide Quality oversight in designated projects activities.
● Supports quality assurance efforts fGMP related facility equipment systems to ensure full GMP compliance.
Typical Accountabilities (per AZ framework regulatory expectations):
● Conduct activities interactions consistent with Company Values in compliance with the Code of Ethics supporting Policies Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics supporting Policies Standards on time. Report potential issues of non-compliance.
In addition, fManagers Project Team Leaders:
● Ensure monitcompliance by team members third parties by (a) positively reinforcing the Code of Ethics all relevant AstraZeneca Policies Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions concerns, (d) immediately addressing reporting, as appropriate, instances of non-compliance.
● Manager Accountabilities at AstraZeneca include Ethical Conduct Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, Fiscal Financial awareness.
● Leaders with accountability fGXP areas are expected to understthe legal regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, equipment) to maintain the Quality system continually improve its effectiveness.
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