Quality Assurance Department – Quality Assurance Operations / P1–P3 / Seishin Plant (Kobe City)

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.

Overall Job Purpose:

• Responsible for product quality assurance of pharmaceutical and medical device manufacturing processes and product testing at the Seishin site

Job Responsibilities:

• GMP compliance for new product launches, establishment of quality assurance systems, and coordination with internal stakeholders; collaborate with domestic and global internal departments to build quality standards and assurance systems for the manufacturing site based on GQP and GMP

• Quality management as a manufacturing site for products marketed in Japan; review of manufacturing and testing records; management of deviations, change controls, and validation

• Investigation and reporting of quality information and product quality issues

• Regulatory inspection and audit support at the manufacturing site, as well as batch release activities

• Quality improvement activities in collaboration with internal overseas manufacturing sites

Required Experience: (mandatory for hiring)

• At least 3 years of experience in manufacturing, quality testing, or quality assurance within the pharmaceutical, medical device, food, cosmetics, or chemical industries

• In consideration of employee well-being and productivity, the company sets a commuting limit of within 90 km from the nearest station to the employee’s residence and within 90 minutes travel time by public transportation using the most economical route. Applicants living beyond this range are generally expected to relocate within commuting distance (company-leased housing is available). This policy also applies in cases where commuting by car is permitted.

Essential Skills / license: (mandatory for hiring)

• Native-level proficiency in Japanese

• Basic English proficiency, with a willingness to further develop language skills

Desirable Skills / license:

• Pharmacist license

Work Location: Seishin Plant (Kobe City)

Scope of Changes to Job Duties: May be assigned to all duties within the company.

Scope of Changes to Work Location: As part of future career development, there may be opportunities for assignments at the Kobe Head Office, Tokyo Branch, Seishin Plant, or overseas offices.

Compensation & Benefits

• Salary: Competitive and commensurate with experience in accordance with company policy.

• Allowances: Housing allowance, commuting/transportation allowance, and others.

• Salary Increase: Available.

• Bonus: Performance-based bonus paid once annually in March of the following year, based on individual and company performance.

• Working Hours: 8:45 AM – 5:30 PM

• Overtime Pay: Paid for non-exempt positions (“Staff” roles only).

• Flexible Working Hours (Flextime System): Available.Flexible hours between 5:00 AM – 10:00 PM (excluding the designated common break period). Minimum daily working hours: 4 hours (2 hours for half-day leave). Core/common break time: 12:00 PM – 1:00 PM

• Smoking Policy: No smoking permitted at the workplace (fully smoke-free environment).

Holidays & Leave:

• Two days off per week (Saturday and Sunday)

• National holidays

• Year-end/New Year holidays and summer holidays

• Annual paid leave and special leave (e.g., bereavement)

Insurance: Employment insurance, workers’ compensation insurance, health insurance, and employee pension insurance.

Retirement: Mandatory retirement at age 60.

Re-employment System: Available up to age 65.

Annual Paid Leave (Granted Upon Hire):

• January–June: 10 days

• July: 5 days

• August: 4 days

• September: 3 days

• October: 2 days

• November: 1 day

• December: 0 days

Probation Period: 6 months (no change in salary or conditions during this period)

職務目的：

• 西神サイトにおける医薬品および医療機器の製造工程・製品試験に関する品質保証業務を担当する

職務内容：

• 新製品上市におけるGMP適合対応、品質保証体制の構築、および社内関係者との調整；GQP・GMPに基づく製造サイトの品質基準・保証体制の構築に向け、国内外の社内部門と連携する

• 日本国内で販売される製品の製造サイトとしての品質管理；製造・試験記録のレビュー；逸脱・変更管理・バリデーションの管理

• 品質情報および製品品質問題の調査・報告

• 製造サイトにおける規制当局査察・監査対応、ならびにバッチリリース業務

• 海外社内製造サイトと連携した品質改善活動

必須経験：（採用必須条件）

• 製薬・医療機器・食品・化粧品・化学品業界における製造、品質試験、または品質保証業務の経験3年以上

弊社では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。

必須スキル・資格：（採用必須条件）

• 日本語ネイティブレベル

• 基本的な英語力、および語学力向上への意欲

歓迎スキル・資格：

• 薬剤師免許

勤務地： 西神工場（神戸市）

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】8：45～17：30

【時間外手当】”担当職”のみ支給

【清算制フレックス勤務】適応あり。フレキシブルタイム：5時～22時内で勤務。

（ただし、一斉休憩を除く）1日の必要最低労働時間：4時間（半日休暇時は2時間）

一斉休憩：12時～13時

【在宅勤務制度】有

【受動喫煙対策】あり 就業場所 全面禁煙

【休日休暇】完全週休2日制（土・日曜日）、祝日、クリスマス、年末年始・夏期

*年間休日125日、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。

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