About the role
Conduct investigation of root cause, create NC/CAPA if necessary and report to quality responsible when quality issue occurs.
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.