- Location
- Buzen, FK, Japan
- Workplace
- Onsite
- Type
- Full-time
- Department
- Manufacturing
- Closing date
- Today
- Source
- Workday
Description
Manage of chemical Testing
- Lead chemical testing team and managing the testing operations thereafter.
- Check contents of submitted test datasheets and submit to quality responsible.
- Conduct investigation of root cause, create NC/CAPA if necessary and report to quality responsible when quality issue occurs.
- Lead various validation activities related to chemical tests such as test method/CIP, etc, by making the protocols, executing tests, collecting data and reporting.
- Create and maintain SOP/DS which are mainly necessary for chemical tests.
- Manage test schedule and work schedule of chemical test team.
Product Testing
- Perform release testing, including Appearance, Identification tests (Glucose, Lactate, Chloride, Sodium, Calcium, Magnesium), pH, Aluminum, 5-HMF, Hydrogen Carbonate, Particulate contamination-visible particles・sub-visible particles, extractable volume, and Assay (Glucose, Lactate, Chloride, Sodium, Calcium, Magnesium).
- Perform mixing solution test to PD products as In-process testing, including measurement of pH, Chloride, Na, Lactate, Mg and Ca.
- Perform incoming inspection test of pharmaceutical ingredients, including ID test or Identification test, Purity tests and Quantitative tests.
- Perform quality test of manufacturing water (WFI, PS, DIW, HPW, HPS, PW), including TOC, Conductivity, Nitrates and Aluminum tests.
- Perform quality tests for PD product’s parts, including verification of barcode quality of APD connector and plastic container test.
Assisting/supporting quality responsible and others
- Make judgement on test reports in absence or on behalf of quality responsible.
- Assess the situation and instruct to relevant department in absence or on behalf of quality responsible.
Equipment & Reagent Management
- Perform daily checks of testing equipment, confirm calibration status, arrange repairs as necessary, and manage consumables used for quality testing.
- Manage testing reagents by monitoring inventory levels and handling simple purchasing and replenishment activities.
- When installation of new test equipment or replacement is necessary, prepare necessary documents such as CAPEX application form and quotations, and submit for approvals.
Meetings / Collaboration
- Attend departmental meetings and Environment, Health and Safety (EHS)-related meetings to share information and exchange opinions related to assigned responsibilities.
- Exchange necessary information with other sites if necessary. It incudes e-mail exchange, phone call, Teams meeting and face-to-face meeting.
Language
Ability of reading/writing/communication by Japanese and English
In particular, ability more than daily conversation level is required on both English and Japanese.