求人情報詳細
NEW 日本イーライリリー株式会社 品質保証/夜勤QAオペレーター(B4)/西神工場
正社員
| 仕事内容 | 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. RESPONSIBILITIES [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). |
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| 経験・資格 |
※求人情報の応募要件全てに該当しなくても、企業様に対して内々に打診したり相談することが可能な場合もございます。一つでも当てはまる方は前向きにご検討下さい。
BASIC QUALIFICATIONCommunication 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. A team-oriented attitude that contributes to quality improvement and safety, with the ability to proactively propose improvements to current conditions. ADDITIONAL SKILLS/PREFERENCES 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). ※更なる詳細事項は、カウンセリング（面談）時にお伝えします。 |
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| 想定年収 | ※ご経験、スキルにより応相談 | ||||||||||||
| 勤務地 |
兵庫県神戸市西区高塚台４-３-３ 西神工場
【受動喫煙対策の有無：有】
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| 福利厚生・待遇 | 在宅勤務制度（随時・固定）、育児支援制度、介護支援制度、女性社員ネットワーク、借上社宅制度、リリーグループ補償制度（医療費・歯科医療費補助制度等） | ||||||||||||
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| 取材班による独自解説 | 開発パイプラインは、単純に候補化合物の数が多いだけではなく、その領域でFirstinclassやBestinclassになる可能性がある化合物が多いことが特徴。 非常に多くの臨床試験が世界同時進行で実施されており、OJTをしながら複数試験の担当となることも可能である。 グローバルの製薬メーカートップ10の中では、唯一大規模合併をせず、単独で成長している。 これは、医薬品企業の価値はイノベーションであり、企業の規模ではないという考えから。従業員のロイヤリティを保つためにも、カルチャーを変えないという選択をしている。 日本市場は本国に次ぐマーケットとして重視しており、特化した分野で確かな地位を築いている。 学閥なし、プロパー優遇なし、職位による差別なし。女性管理職比率は30%以上と業界内トップ。人物をフェアに評価する社風。 「女性が働きやすい環境」「多様な働き方」が制度だけではなく、各社員の意識に根付いている。電話会議のシステムが普及しているため、各都市間の会議も円滑に実施されており、在宅勤務制度も利用しやすい。オフィスにはオープンハブスペース、カフェテリアの他ヨガスペース等もあり、社員間の交流も活発。 多様な働き方をしている社員が多いので、お互いの勤務状況への配慮、理解があり、在宅勤務や時短勤務をしている方もきちんと評価されており、実際に管理職に昇進された方もいる。 | ||||||||||||
| Recruiting No. | 01000692001073 |
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