At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
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.
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).
BASIC QUALIFICATION
- 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.
- 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).
Eli Lilly Japan社員の方へ、社内公募へ自ら応募して異動/転勤する場合のサポート内容はビジネスニーズに基づき異動/転勤する場合と異なりますので、あらかじめ応募にあたっては、詳細は以下リンク先にある情報をご確認とご理解を頂くようお願いいたします。
https://now.lilly.com/landingoverview/JP-change-in-career-system/JP-changes-in-my-career-faqs
社員のウェルビーイングと生産性の観点から、自宅最寄り駅から勤務地までの通勤距離が90㎞以内かつ最安経路での公共交通機関の所要時間が90分以内の範囲を、通勤可能上限としています。それよりも遠方にお住まいの場合は、通勤可能な範囲にご転居いただくことを原則としております。（借上社宅の貸与あり）。車両通勤を認める場合においても、上記を適用します。
就業場所：西神工場（神戸市内）
従事すべき業務の変更の範囲 ：当社業務全般
就業場所の変更の範囲 ：将来のキャリアの一環として、神戸本社・東京支社・西神工場・ 海外オフィスでの勤務をする場合もありうる
＜処遇＞
【給与】 当社規定により優遇します。
【諸手当】住宅手当、通勤交通費など
【昇給】有り
【賞与】年一回 個人業績結果及び会社業績結果に基づく業績変動賞与を翌年3月に支給する。
【勤務時間】20:00-08:00 (休憩時間 90分）12時間の交替制勤務の1カ月単位の変形労働制
【時間外手当】”担当職”のみ支給
【清算制フレックス勤務】適応なし
【在宅勤務制度】無
【受動喫煙対策】あり 就業場所 全面禁煙
【休日休暇】固定シフト制 年間休日195日前後（年により変動あり、シフトカレンダーによる）、年次有給休暇、慶弔等
【保険】雇用・労災・健康・厚生年金保険
【福利厚生】住宅援助制度、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）
【定年制】有（60歳）
【継続雇用制度】：有（65歳まで）
【有給休暇】
年途中で入社した社員に対する年次有給休暇は、次の入社月の区分に従い入社翌月1日に付与される。入社日にかかわらず、その年の12月31日をもって、勤続年数が1年経過したものとみなし、翌年1月1日に翌年度の年次有給休暇が付与される。
入社月 1-6月 7月 8月 9月 10月 11月 12月
付与日数 10 5 4 3 2 1 0
【試用期間】 6か月間 試用期間中での賃金の違いはありません。
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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