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: Lab operations must be compliant with the following laws and regulations (but not limited to)
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.
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.
Knowledgeable of science.
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.
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.
Primary Location Japan-Shizuoka-Ken-Fuji-
Organization Janssen Pharmaceutical K.K. (7195)
Job Function Quality
Requisition ID 2105911914W