会社概要

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.

求人内容

TA: Medical Device

Purpose:

The QA Specialist is responsible for providing quality assurance support for quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process, or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements.

Responsibilities:

• Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products.
• Perform under own manager’s supervision in the 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.
• Participate in training and education programs for various aspects of quality assurance.
• Responsible for project teams in planning, preparation, review and approval of quality documentation.
• Coordinate and investigate quality events such as deviations, nonconformances, product complaints and corresponding action plans including decisions.
• 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 and deliver training and education programs for various aspects of quality assurance.
• Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
• Manage GMP inspection by PMDA (NDA, PCA and periodical) and Foreign Manufacturer Accreditation (FMA) with collaboration of manufacturing site and AbbVie’s regulatory department.
• Manage GMP inspection by PMDA (NDA, PCA and periodical) with collaboration of manufacturing site and AbbVie’s regulatory department.
• 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 change plans for local actions including local SOP management. Assist with local relabeling and complaint handling.
• Participate in / coordinate special project assignments as determined by GQP manager.

資格

Qualifications:

• Bachelor’s degree in chemistry, Pharmacy, Biology, other technical / scientific area.
• 3+ years’ experience in quality assurance, operations, regulatory or relevant experience. Experience at manufacturing site is preferred.
• 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 and regulations.
• Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.
• Strong written and oral communication skills. Proficiency in English.
• Excellent interpersonal skills.
• Strong computer skills and knowledge of enterprise systems such as TrackWise.
• Strong influencing, motivational, interpersonal and relationship building skills at all levels.
• Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
• Negotiation skills, effective collaboration and ability to anticipate needs and requirements.

Runs small project to deliver tactical results.

その他の情報

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。