<Lead and Manage the Product QA Group>
•    Establish and maintain the appropriate organization in order to ensure delivery of job objectives and fulfil responsibilities. 
•    Train and develop individuals by coaching and using the Performance Management Process in order to maximize their contribution to the business.
•     Determine the manpower, materials, equipment and services required to ensure that the team is suitably resourced to carry out the required activities.
•    Promote fair work/life balance for staff through effective work planning and resourcing and ensure staff operates in accordance with AZ code of conduct, SHE and all applicable AZ policies.

<Manufacturing Release>
•    Assure quality of product in Maihara and manage batch disposition process.
•     Cooperate with SCM and PET planners for ensuring the batch release in a timely manner. 

<Quality Management>
•    Manage Deviation and Quality Defect in collaboration with PET and SCM.
•     Manage Deviation, Quality Defect, CAPA and Change Control tracking process.
•     Approval of documents relating to validation.
•   Prepare and deliver training for users for QMS.
•    Alignment of QMS process in line with Global / Local
•     Ongoing review to ensure that the QMS complies with Q&CM and local Japanese requirements.
•     Generation of procedures, working standards and documentation to allow staff to operate the QMS.

<NPIs and Project Management>
•       Working in conjunction with the Project leader and member, launch a new product in accordance with the schedule.
•       Working in conjunction with the Stakeholder, implement a process for review of the progress.
•     Manage preparation of dossier. 

<Ensure manufacturing sites in compliance>
•      Ensure that the core GMP documents are in place and updated.

<Support to QA Management team and in Operations general>
•     Facilitate and coordinate issues among multiple functions (Global/Japan)
•     Deputize for QA Director.

<General Requirement from AZ Global>
•    Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation,  to assure a functionally independent quality unit.
•      Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
•     Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through participation in management reviews and through advocating continual improvement.

経験 Experience　必須

•    Experience in quality assurance within a pharmaceutical manufacturing environment
•    Project Management skill

資格 License　必須
•    Masters degree or secondary degree (business, operations or quality management)

能力 Skill-set　必須 Mandatory

•Knowledge of Quality Management Systems and JPAL/GMP/GQP requirements
•Understanding of Quality Risk Management
•Project Management skill (planning, problem solving)
•Oral and Written Communication skills (J&E)
•Negotiation skill
•Facilitation skill
•Problem solving skill
•Leadership Capability (Level2)

歓迎 Nice to have

•CMC-related special knowledge
•Knowledge of global GMP (FDA, EU) and ICH guideline
•Computer literate in Word, Excel, Power Point, Project and other applications

語学 Languages　必須

Excellent oral and written communication skills both in English and local language(s)

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.