Requisition ID: 1805663946W
- 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)
COMPLIANCE RESPONSIBILITIES:（If needed）
operations must be compliant with the following laws and regulations (but not
- 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
- 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,
- 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
- Review and ensure of integrity and correctness of laboratory
- Performs lab equipment lifecycle
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
- 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
- Report all incidents, accidents, and near
- Collaboration and teamwork
TOOLS, MACHIERY AND MATERIALS:
- Proficient with Microsoft Office software programs and Empower are
- Proven ability to effectively use software applications for data
entry, data analysis, word processing, presentations, and calculations is
Janssen Pharmaceutical K.K. (7195)ジョブ
Quality ControlRequisition ID