Johnson & Johnson キャリア

【Janssen】Quality Control Chemical Analyst

富士市, 日本
Quality Control


仕事内容

Requisition ID: 1805663946W

  • 職務概要DESCRIPTION:

  • 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)

  • 法規制の順守に関する責任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 software management.
  • 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.

  • その他 OTHER REQUIREMENTS:

  • N/A

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
1805663946W