AstraZeneca
From AstraZeneca's careers page
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The incumbent is responsible for the Quality management of assigned External Suppliers within Procurement Quality AsiaPac teams. They are responsible for all Quality activities that directly support execution of Quality Management of Suppliers for assigned suppliers. This includes, but is not limited to, the Quality System oversight and/or performance of the following activities: change control, product quality complaint, S&L complaint and deviation investigations, quality issue management and escalation, Quality Agreements (establishment and maintenance) between AZ and External Suppliers and between EQ and AZ Operations Sites.
Within the External Quality (EQ) organization the job holder is responsible for the oversight and ownership of Quality System(s). They will support the Quality Professionals involved in Quality Supplier and Product Supply Chain Management within the assigned categories.
In addition, the preparation and submission of periodic Supplier Quality Assessments, Regulatory Agency interactions and serving as Quality leaders on NPI, new supplier introductions, In Licensing, strategic sourcing projects, process optimization and product transfer projects, as these relate to Quality Supplier management, are within the scope of this role. Regulatory Agency interaction includes preparation for, and management of, Regulatory Agency inspections at External Suppliers and AZ sites (when External Suppliers are assessed).
Skill-set Mandatory
Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
Excellent oral and written communication skills [English and local language(s)]
Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)
Strong problem solving skills
Strong negotiating/influencing skills
Ability to work independently under his/her own initiative.
License Mandatory
Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering (Note: there may be specific additional requirements depending on the regulations in each country). Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role.
Experience working in a PCO/PET organization or Lean/Six Sigma training.
Multi-site / multi-functional experience
Proven experience in Quality Assurance or combination of Quality and Technical
Masters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field
Languages Mandatory
Japanese：N1 level
English：TOEIC 800+
Others Mandatory
Ability to travel nationally and internationally as required approximately 10% of their time.
Others Nice to have
PCO members or equivalent team
Category/Sub Category Team members
Quality and other support groups within or across sites
Regulatory Affairs (including GQO CMC RC)
GQO
Global Supply Managers/Directors
Pharmaceutical, Technology and Development, and Pharmaceutical Sciences
Work Location
Osaka/Maihara/Tokyo
Closing Date
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 authorization and employment eligibility verification requirements.
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