Location: *** 6-12 months in Jiangsu, permanent location in Qingdao
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).
* Cross functional interaction with both internal and external colleagues in
Operations and Quality to ensure full compliance with AZ standards and local
regulations.
* 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
* 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, QA, 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, QA, manufacturing and technical functions to
provide Quality oversight in designated projects and activities.
* Supports quality control efforts for GMP related facility and equipment
systems to ensure full GMP compliance.
The incumbent has expert level understanding of china legislation, cGMPs,
Validation and Quality Systems, specifically deviations and change controls and
maintains current knowledge of lab systems and testing technology.
The incumbent is capable of influencing stakeholders and partners and be able
to effectively problem solve complex quality control issues and actively
communicates with colleagues.