西神品質保証/夜勤QAオペレーター

必須

• Communication skills enabling collaboration and consultation with others both within and outside the team.
• Attentiveness and accuracy to detect documentation errors, calculation mistakes, and omissions, along with the ability to manage multiple matters in parallel.
• Experience handling quality events such as deviations, change controls, and complaints, including experience developing and driving root cause analysis (RCA)/CAPA, or equivalent quality investigation experience.
• Ability to operate internal systems such as SAP and MURATA (English proficiency sufficient to understand English-language displays).
• Ability to make autonomous quality judgments and handle quality events in accordance with quality standards and procedures.
• Word, Excel, and PowerPoint skills at the level expected of general administrative staff.

歓迎

• Background in pharmacy, chemistry, biochemistry, agricultural science, or similar, or completion of higher education in a science-related field.
• Hands-on GMP experience in industries such as pharmaceuticals, chemicals, cosmetics, or food (3+ years recommended).
• Knowledge of GMP Ministerial Ordinance and QMS Ministerial Ordinance.
• English proficiency (writing/reading skills, TOEIC score of 600 or above).

求める人物像

• A team-oriented attitude that contributes to quality improvement and safety, with the ability to proactively propose improvements to current conditions.

使用ツール

JOB POSITION OVERVIEW

• This position is responsible for advanced Quality Assurance Operations duties. The role provides day-to-day QA support for manufacturing and warehouse operations, while proactively leading and coordinating quality events (deviations, change controls, and complaint handling), including investigations and cross-functional coordination.
• In addition to reviewing batch manufacturing records and testing records and supporting shipment release decisions, this position leads troubleshooting efforts to help maintain and improve the quality system and stable supply. The role is also expected to proactively propose and drive improvement activities, collaborating both within the team and across other departments.

[1] Safety

• Act in accordance with safety requirements, actively participate in safety initiatives such as B-Safe and safety walks, and cooperate in addressing safety-related issues.
• When a safety concern is identified, promptly report it to management/relevant departments and implement or support corrective actions.

[2] Manufacturing & Warehouse QA Support

• Perform duties in compliance with Good Documentation Practice and SOPs.
• Confirm completeness at the time of batch manufacturing record issuance.
• Perform initial review and data entry of batch manufacturing records for shipment release decisions.
• Support GMP and regulatory compliance in warehouse and manufacturing processes.
• Confirm GMP compliance of product/material storage status and inbound/outbound records, taking the initiative to respond and coordinate when issues arise.
• Change status (e.g., Usage Decisions) for intermediate products and materials using systems such as SAP and MURATA.
• Support project initiatives required by projects and the Quality department.
• Create, review, and troubleshoot Activity Planning Records and similar items using electronic systems.
• Confirm the integrity of document filing and archive management.

[3] Quality Event Management

• Take the lead and responsibility for quality decisions and handling of quality events.
• Lead deviation initiation and investigation: conduct root cause analysis (RCA) and develop/follow up on corrective and preventive actions (CAPA).
• Support change control assessments: evaluate the quality/regulatory impact of changes and follow up on resulting actions.
• Conduct initial investigation and assessment of product complaints and quality incidents, and support communication/coordination with overseas manufacturing sites as needed.
• Create records and manage progress for deviations, change controls, and complaint handling using electronic systems.
• Conduct trend analysis of quality events and submit improvement proposals to management and relevant departments.

[4] Documentation & System Operations

• Prepare and quality-check materials and documents used for meetings, teleconferences, Annual Product Reviews, etc.
• Draft and revise SOPs, and communicate revision content to the team.
• Appropriately operate internal electronic systems such as SAP and MURATA to maintain the accuracy and completeness of records.

[5] Team Leadership & Capability Building

• Provide OJT and guidance to B3-level and below staff to raise the overall quality capability of the team.
• Share and roll out solutions to operational issues within the team.
• Proactively propose and drive improvement activities (continuous improvement suggestions).