J&J Family of Companies 【Consumer】品質/コンプライアンス スタッフ in 千代田区, Japan
Scope of product category: Consumer Products marketed by JJKK (Quasi-Drug, Cosmetic, Medical Device, OTC, and General Commodity).
Ensure ongoing compliance to local regulations for the products in scope – this includes the ownership of GQP and GMP responsibilities.
Day-to-day GQP/GMP activities such as in-coming inspection, batch record review, change control, deviation management, document control, training management, batch disposition, and so on.
Support JJKK Consumer Company execution to apply quality requirements.
Execute Products quality trouble shooting.
Communicate with manufacturers to ensure effective root cause analysis and CAPA executed.
Continuously monitor and improve quality systems & procedures to ensure full compliance to applicable Regulations/Guidelines, Quality Policy, Enterprise Standards, and Global/Regional/Local procedures.
Review and evaluate all quality information (product quality complaints) and analyze it if necessary.
+3 years of experience in quality management activities in healthcare industries (Pharmaceuticals, Quasi-Drugs, Cosmetics, Medical Devices, or General Commodities)
Experience in cross-functional projects/initiatives
＜Skills and Capabilities＞
Verbal and written communication skill in Japanese and English
Computer skill with MS-Office applications (Word, Excel, and PowerPoint)
Sufficient knowledge of global/local regulations such as J-PMD Act, cGMP, GQP, GDP etc.
Good presentation skill
Problem solving and Decision making
- Pharmacist preferred
Johnson & Johnson K.K. (8235)