■ 職務内容 / Job Description

The Quality Assurance Supplier Manager (QASM) provides QA management of assigned Local and Global Suppliers within the AZ network. They are responsible for all materials and components that directly support the manufacturing and packaging of AZ products. This includes, but is not limited to, updating and maintaining the Supply Chain Assurance system (SCA), incoming QC components and specifications, Quality System oversight and/or performance of the following activities: change controls, product quality complaints and deviation investigations, quality issue management and escalation, product release, QA Agreements (establishment and maintenance) between AZ and External Suppliers.

•    Communicates quality related issues with appropriate Stakeholders within the organization.
•    Supports and interacts with the Global External Sourcing (GES) professionals involved in QA Supplier Management and Product Supply Chain Management within the AZ network at a Global level.
•    Supports the World Wide Audit Group (WWAG) with supplier audit preparation and provides specific vendor details from an AZ Mt. Vernon standpoint.
•    Supports and interacts with Regulatory Agencies during site audits and inspections.
•    Regulatory Agency interaction includes preparation for, and management of, Regulatory Agency inspections with regards to Supplier Management.
•    Supports new supplier introductions, new component and material qualifications via the change control process.
•    This position requires strong cross-functional ways of working with non-QA members across the Organization.

JOB RESPONSIBILITIES:
•    Liaise with Suppliers to ensure successful delivery of projects.
•    Make decisions and advise the Supplier Management Team regarding quality issues within their area of expertise.
•    Responsible for Quality Assurance Supplier Management including but not limited to: Quality Risk Assessments; Quality Assurance Agreements; trending and reporting of data; assessing, reviewing and improving quality systems at Suppliers; attendance at Quality and Business Review Meetings.
•    Maintains a high level of understanding of relevant production processes and quality systems.
•    Performs the QA review and/or approval of the following cGMP documentation for Suppliers:
•    Change Requests
•    Product Quality Reviews or Supplier Quality Review (GDMS)
•    Quality Investigations (Deviations, Product Quality Complaints)
•    Works with applicable site support groups or cross-functional teams on projects (capital and non-capital) that impact the assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
•    Communicates and builds cooperative relationships with third-party colleagues and within AZ.
•    Performs QA review of the following GMP documentation as it relates to the processing to which the position is aligned: Change Requests, Batch Records, Quality Investigations (Deviations, Product Complaints), Standard Operating Procedures
•    Supports the coordination and development of supplier’s Quality Agreements in compliance with AZ Quality Systems for supplier management
•    Maintains a high level of understanding of relevant production processes and quality systems
•    Stays abreast of evolving regulatory compliance practices

Quality 
•    Executes processes in compliance with cGMPs, site policies, work instructions, and SOPs.
•    Immediately reports issues to supervision that have potential for product quality impact.

Safety 
•    Maintains a safe work environment by following all Health & Safety policies and procedures; immediately reports potential unsafe conditions to supervision
•    Uses Personal Protective Equipment (PPE) as necessary

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【経験 / Experience】

＜必須 / Mandatory＞

•    Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering and > 5 years experience in pharmaceutical industry in roles covered by GMP oversight.
•    Strong demonstrated knowledge of cGMPs, Quality Systems, regulatory principles and the pharmaceutical supply chain environment
•    Excellent interpersonal, verbal, and written communication skills with the ability to communicate with all levels of the organization
•    Ability to prioritize workload and manage multiple and varied tasks with minimal guidance from management
•    Ability to work independently as well as to effectively collaborate to lead a team.
•    Ability to understand underlying issues / needs of customers and proactively engages the customer in development or identification of solutions, products or services
•    Ability effective decisions within the role without seeking unnecessary permission
•    Experience with Microsoft Office applications (i.e. Excel, Word, PowerPoint)
•    Sets himself / herself high standards and obtains feedback to ensure that they are met
•    Holds other accountable for high standards and clarifies what needs to be accomplished, why, and the consequences for the individual and / or the organization　
 

＜歓迎 / Nice to have＞

•    Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
•    Multi-site / multi-functional experience
•    5 + years experience in Quality Assurance
 

【資格 / License】

＜必須 / Mandatory＞

•    Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering
 

【能力 / Skill-set】

＜必須 / Mandatory＞

•    Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering　and > 5 years experience in pharmaceutical industry in roles covered by GMP oversight.
•    Strong demonstrated knowledge of cGMPs, Quality Systems, regulatory principles and the pharmaceutical supply chain environment
•    Excellent interpersonal, verbal, and written communication skills with the ability to communicate with all levels of the organization
•    Ability to prioritize workload and manage multiple and varied tasks with minimal guidance from management
•    Ability to work independently as well as to effectively collaborate to lead a team.
•    Ability to understand underlying issues / needs of customers and proactively engages the customer in development or identification of solutions, products or services
•    Ability effective decisions within the role without seeking unnecessary permission
•    Experience with Microsoft Office applications (i.e. Excel, Word, PowerPoint)
•    Sets himself / herself high standards and obtains feedback to ensure that they are met
•    Holds other accountable for high standards and clarifies what needs to be accomplished, why, and the consequences for the individual and / or the organization

＜歓迎 / Nice to have＞

•    Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
•    Multi-site / multi-functional experience
•    5 + years experience in Quality Assurance
 

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese：Yes

英語 English：Yes

【キャリアレベル / Career Level】

D or E

【勤務地 / Work Location】

Osaka

Date Posted

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.