- 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.
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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.
- 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.
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.
- Strong leadership skill to perform cross functional tasks.
- Logical thinking to make regulatory strategy.
- 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.
(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.
- 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.
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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.
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