Johnson & Johnson キャリア

【Janssen】Quality Control Chemical Analyst

富士市, 日本
Quality Control


仕事内容

Requisition ID: 1805638183W

This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedure at Fuji QC as required by Good Manufacturing Practice (GMP)
REGULATORY COMPLIANCE RESPONSIBILITIES:(If needed)
Lab operations must be compliant with the following laws and regulations (but not limited to)
  • GMP
  • Narcotics and Psychotropics Control Law
  • Official compendium such as JP etc.
  • The Pharmaceutical Affairs Law
EHS laws such as Poisonous and Deleterious Substances Control Law etc.
 
職務の詳細ESSENTIAL DUTIES:
  •   Performs analytical testing activities such as chemical test, microbial test, sampling, packaging material test, method validation and technical transfer activities relation to routine operations and ad-hoc request, so as to ensure that all methods meet regulatory requirements such as JP, GMP guidelines and registered dossier, etc.
  •   Achieves competency in Fuji QC laboratory methods and procedures.
  •   Trains other QC analysts in QC activities such as laboratory methods and how to use lab equipment when requested.
  •   Writes and reviews laboratory document (SOPs, WIs, and IQ/OQ and PQ protocols) as directed by company policy and GMP.
  •   Deals with non-conformance/deviations/CAPA in an accurate and timely manner.
  •   Maintains and develops knowledge of technology as well as GMP standards.
  •   Performs chemical substance and Reference standards purchase/storage/stock control/update/trouble shooting/disposal.
  •   Review and ensure of integrity and correctness of laboratory test results.
  •   Performs lab equipment lifecycle management (installation/calibration/validation/qualification/trouble shooting/update/disposal) and related softwaremanagement.
  •   Review and archive use logs of lab equipment monthly basis.
  •   Ensures timely completion of the stability test and reports in accordance to the plan.
  • Escalates any deviations from the plan immediately when identified.


資格

教育/経験EDUCATION/EXPERIENCE:(Essential)

  • Knowledgeable of science.
教育/経験EDUCATION/EXPERIENCE:(Desirable)
  • Knowledgeable of PMDA/MHLW/JP regulatory requirements applicable to biologics and/or pharmaceuticals.
  • Demonstrated knowledge and testing experience in PMDA/MHLW/JP approved QC laboratory.
技能COGNITIVE SKILLS:
  • Credo value of integrity
  • Comply with EHS rules and procedures at all times.
  • Report all incidents, accidents, and near miss events.
  • Collaboration and teamwork
資格及び技能EQUIPMENT, TOOLS, MACHIERY AND MATERIALS:
  • Proficient with Microsoft Office software programs and Empower are required.
  • Proven ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations is requested.


プライマリ場所
日本-静岡県-富士市
組織
Janssen Pharmaceutical K.K. (7195)
ジョブ
Quality Control
Requisition ID
1805638183W