Associate Product Assurance 2

Bristol Myers-Squibb Consumer PD
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  • 9/23/2019 4:10:22 AM

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

概要 (High-level Description; including manage team/individuals or not)

  • Contribute to maintain stable supply of high quality BMSSKK products to the market as quality experts.
  • Contribute to GQP performance by following Pharmaceutical and Medical Devices Law and by cooperating with BMSKK Aichi Plant, subcontracting manufacturers and inside departments including overseas.
  • Proactively work with GVP and contribute to maintain/renew BMSKK Marketing authorization License.
  • Appropriately analyze the quality information received and minimize the risk derived from quality issue.
  • Support Quality Assurance Supervisor.
  • 安全管理部門と連携しながら、BMSKKの製造販売業許可の維持・更新に貢献する。
  • Arrange quality agreements between manufacturing sites where approved products are manufactured.
  • Enforce periodical on-site auditing to the manufacturer and confirm if proper product/quality control is enforced. Also, if audit resulted for remedy, propose CAPA to QAS.
  • Analyze and evaluate product quality and propose and enforce quality improvement counterplan.
  • Enforce preventive measures for deviation reoccurrence.
  • Quickly investigate the cause of the complaint for BMSKK product quality and prepare written report. Visit customers if necessary and explain the report.
  • By evaluating and confirming the manufacturing change method and the testing change method by following the change control SOP, enforce the suitable change management.
  • File documents following Pharmaceutical and Medical Devices law, GQP ministerial order and BMSKK SOP and train related departments on GQP following the yearly schedule.
  • Take control of the manufacturing information for variance on manufacturing method, testing item, and other necessary written information in the manufacturing approval document.
  • 現在製造販売承認を有している製品に関与している製造業者等と品質に関する取決めを締結するための書類を作成する。
  • 製品の品質等に関する情報を分析、評価し品質向上の為の対応策を立案・実施する。
  • 薬機法、GQP省令、BMSKKのSOPに従い、適切な文書管理を行い、GQP教育を年間計画に従い関連部署に実施する。
  • 製造販売承認書に記載された製造所情報、製造方法、試験項目、その他必要な項目と、製造所での実態に齟齬が出ないように管理する。

必要な知識/スキル (Required knowledge/skills)

  • Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.
  • Knowledge of accreditation/renew of accreditation for foreign manufacturer, regulatory application for periodical GMP compliance inspection etc.
  • 医薬品医療機器等法、GQP省令、GMP省令、関連法令に関する知識。
  • Strong leadership skill to perform cross functional tasks.
  • Logical thinking to make regulatory strategy.
  • 規制当局及び関連部署との良好な関係を築くためのコミュニケーションスキル

(Technical Skill/テクニカルスキル)

  • Managing and supervising skill for appropriate manufacturing and quality control of the manufacturing sites (API site, Formulation site, etc.) listed in approved files.
  • Capabilities of analyzing the management results of manufacturing sites, make instructions for improvement if necessary.
  • 製造販売承認書に記載された製造所(原薬製造所、製剤製造所等)の適正な製造管理、品質管理を管理監督する能力。
  • 製造所を管理監督した結果を解析し、必要があれば改善を要求する能力。

(Desirable / 以下の経験があることが望ましい。)

  • Quality control testing operation at the manufacturing sites, drug production or packaging related operations.
  • 製造管理及び品質管理業務に関する薬事申請業務経験
  • Pharmacist license desirable. / 薬剤師免許があることが望ましい。
  • Understand English documents. / 業務に関連した英文資料を理解する能力がある

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Working with Us

By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases.

Explore Job Opportunities

A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move.

Come Meet Our Team

Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more.

For US Applicants Only

Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact adastaffingsupport@bms.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, click here.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here: EEO is the LAW and Supplemental Information.

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