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Lilly <研究開発・メディカルアフェアーズ統括本部> Asia-Pacific Regional Center for Product Complaint /担当/担当課長/専門課長 /神戸本社 in Kobe office, Japan

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

< 職務内容>

·Assessment, Sample Analysis and related activities for the external product complaints reported from Asia-Pacific affiliates.


Assessment / アセスメント

·Assess product complaint information, designate an appropriate complaint level, and assign suitable complaint and/or analysis category(ies).


·Determine the need for additional investigation and forward product complaint records to the proper manufacturing or packaging quality unit for further investigation, as required.


·Build and maintain working relationships with manufacturing / packaging sites that supply medicine to Asia-Pacific affiliates.


·Where additional information may aid in determining the root cause of the product complaint, obtain supplementary information from related parties.


·Determine the need for the product complaint sample.


·Respond to the customer with educational information, as applicable, during customer follow up endeavors (e.g., request for batch number and/or product complaint sample).


Sample analysis / 現品調査

·Receive product complaint sample returned to Lilly into the APRC laboratory.


·Perform visual and/or functional analysis of returned complaint samples.


·Assess the results of the returned complaint sample, including impact on: complaint level; complaint category(ies); investigating site; and additional investigation requirements.


·Document analysis results into the complaint database and associated records.


·Perform follow up activities with the product complaint reporter or related contacts, as necessary, to obtain additional details associated with the returned complaint sample.


·Forward complaint record and sample to the appropriate manufacturing or packaging site for further investigation, as appropriate.


·Evaluate the completed complaint investigation and identify an appropriate customer response.


·Manage the operation, cleaning and maintenance of APRC laboratory equipment.


Related activities / 関連業務

·Establish working relationships & influence outcomes with manufacturing / packaging sites that supply medicine to Asia-Pacific affiliates to deliver complaint investigations timely.


·Participate in new product design and pre-launch preparation projects to identify and address potential customer product complaints.


·Contribute to post-launch product complaint monitoring activities.


·Comply with GQP/QMS ministerial ordinance.


·Serve as a subject matter expert (SME) for applicable APRC procedures and work instructions.


·Participate in departmental process improvement activities.


·Work effectively within a team to deliver results in a defined time line.


Associate/Sr Associate/Manager - APRC

< 必須経験/スキル・資格>

·A bachelor’s degree in health science related field (e.g., pharmacy, chemistry, biology, or engineering).


·Experience in pharmaceutical manufacturing and/or quality environment (at least 1 year).



·Japanese (with native fluency) and English communication skill (e.g., Versant score: minimum 47, TOEIC score: 730)

日本語(ネイティブ)及び英語でのコミュニケーション能力(Versant 47点/TOEIC 730点或いは同等の英語力)

Eli Lilly Japan社員の方へ、






【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。





【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、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




【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の翌月1日に付与さる。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ございません

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