Senior QA Specialist or QA Manager
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Minato City, Tokyo
- オペレーション
- TBD
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Responsibilities:
・Responsible for the integration and support of quality regulations especially Japan Pharmaceutical Affairs Law
and GQP/QMS ordinance: drug, biologics, device and/or combination products.
・Responsible for design of effective quality systems, procedures and/or processes within cross functional teams
to ensure compliance as well as efficiency throughout our quality systems. Evaluate, analyze
and trend quality indicators, data and performance metrics; communication and elevation of
affiliate compliance status and risk while maintaining a continuous improvement objective.
・Partner, coordinate and support activities related to product actions in the affiliate.
・Responsible for project teams in planning, preparation, review and approval of quality documentation.
・Perform assessments to determine compliance to processes, procedures and regulations
to identify potential gaps and mitigate and implement improvements. Support internal
and external quality inspections and audits including reporting, response to observations
and tracking of action plans.
・Participate in training and education programs for various aspects of quality assurance.
・Coordinate and investigate quality events such as deviations, non-conformances, product complaints
and corresponding action plans including decisions.
・Quality management of supplier qualification program including performance monitoring for key suppliers,
QTA management and assessments.
・Provide guidance and support for all activities governed by Good Storage and Distribution Practices
including monitoring of controlled temperature and cold chain shipments.
・Represent affiliate QA in regional, global and cross functional teams, projects and programs, as appropriate.
・Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement
including review of procedures and process to identify areas of opportunity.
・At introduction of a new product or change of an existing product in Japan, facilitate technology transfer
such as test method and/or manufacturing method to local test/manufacturing sites, closely cooperating
with relevant functions such as global science and technology and/or QA.
・Manage GMP/QMS inspection by PMDA (NDA, PCA and periodical) and Foreign Manufacturer Accreditation (FMA)
and Foreign Manufacturer Registration (FMR) with collaboration of manufacturing site
and AbbVie’s regulatory department.
・Partner with stakeholders across the enterprise to gain a better understanding of processes external to
QA to determine best steps forward.
・Responsible for partnering and overseeing support activities related to product actions in the affiliate.
Oversee coordination and investigation of key quality systems (ie. CAPA, product complaints)
ensuring KPIs are being met.
・Participate in / coordinate special project assignments as determined by GQP manager.
・Mainly in charge of test method transfer and lab issue management by coordinating
with local Third-Party Lab(s) /manufacturer and global SMEs.
Qualifications:
・Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or
other technical/scientific area preferred.
・5+ years’ experience in quality assurance, quality oversight or relevant experience.
・Technical knowledge in as many of the following areas as possible: Quality, Regulatory,
Process Sciences, Manufacturing Operations. Knowledge and familiarity with product, process,
and both internal and external customer requirements.
・Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device,
biologics and pharmaceutical products preferred.
・Experience working independently. Works well with manager guidance to complete tactical objectives
while able to manage own time effectively.
・Strong oral and written communication skills needed. Proficiency in English.
・Excellent interpersonal skills.
・Strong computer skills and knowledge of enterprise systems such as TrackWise.
Key Stakeholders:
Local Affiliate functions, Commercial QA team, Regulatory/Competent Authority,
Suppliers/Service Providers, Product Quality, Global functions, Commercial Quality Systems Manager
AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ&インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別(妊娠を含む)、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。