Sr. Process engineer, Pharmaceuticals, Shiga , 13.5M

滋賀県 外資系企業 8,000,000¥ - 13,500,000¥ 外資系企業
  • Working with Professional team in the market
  • rewarding and Challenging task will be provided

企業情報

  • The company's core competencies are in the fields of health care and agriculture.
  • Company has a diverse portfolio of products with businesses in pharmaceuticals, consumer health and crop science.

職務内容

  • Support of Current GMP(cGMP) production for market supply
  • Maintain CMC manufacturing records and documentation (authoring and reviewing technical reports,protocols, technology transfer documents, CMC sections in regulatory filings, TRDs)
  • Supporting technology transfer and process development to cGMP manufacturing, site transfers ofcommercial manufacturing processes as required
  • Providing ongoing technical support for change control, deviation investigations and CAPAmanagement as required during development and commercial manufacturing of products
  • Ensure transfer of knowledge within the global production network: data evaluation and sharingbetween sites; exchange of process optimization opportunities and regular
  • Provide process and product expertise and solutions in global trouble shootings

理想の人材

  • Great experience in Chemical, Biomedical, Industrial Engineering etc. plus Production and/or Engineering experience in the Pharmaceutical industry
  • Good experience with cGMP, international guidelines and regulations with knowledge of systems and standard documentation required in the pharmaceutical industry.
  • Experience in support of launch, tech transfer, and/or sustaining cGMP commercial drug product manufacturing process operations in bio-pharmaceuticals
  • Experience / technical knowledge with drug product manufacturing required (i.e. formulation,aseptic filling)
  • Knowledge of process validation requirements and cGMP regulatory guidelines
  • Fluent in Japanese and English

条件・待遇

Annual income up to about 13.5 million yen

コンタクト
Bon Siripairoj
求人番号
4156911
電話
+813 6832 8985

求人情報

勤務地
雇用形態
担当コンサルタント
Bon Siripairoj
担当コンサルタントの電話番号
+813 6832 8985
求人番号
4156911
企業タイプ