Johnson & Johnson キャリア
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【Janssen】Quality Control Chemical Analyst
Requisition ID: 1805638183W
- Narcotics and Psychotropics Control Law
- Official compendium such as JP etc.
- The Pharmaceutical Affairs Law
- 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.
資格及び技能EQUIPMENT, TOOLS, MACHIERY AND MATERIALS:
Janssen Pharmaceutical K.K. (7195)