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 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.
This job position is for a GCP medical auditor. The position is office-based located at the Lilly Kobe affiliate office.
Position Brand Description:
The Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through the execution of internal and external audits in support of pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance and consumer information quality (CIQ) for Lilly. Through auditing, the Global Quality Auditor assures that GXP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations, applicable guidelines and industry standards.
GQAAC is operating as a valued business partner and taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance. The Quality Auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight.
Key Objectives/Deliverables:
The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:
Auditing:
Scheduling, preparing, conducting and reporting GQAAC audits and assessments of GXP operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.Participate in or lead the risk assessment of GXP operations in support of generating the GQAAC risk-based annual audit plan.Appropriately escalate any compliance issues.Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
Global Quality – Business Related Responsibilities:
Participate in or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.Participate in or lead the preparation of organizational metrics and trending of audit findings, when required.Provide audit-related advice to GXP operations on the interpretation of corporate and regulatory GxP requirements (standards/policies/procedures) related to quality management, when required.Establish and maintain relationships with relevant business areas and regulatory authorities, including support for regulatory inspections, when required.Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.Personnel Development:
Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.Complete required training for the roles identified in the Individual Training Plan (ITP)Be continually aware of current industry trends and regulatory agency interpretation of GxP requirements.Seek self-development in GxP areas (e.g. attend training courses, conferences or association meetings) and share such information and knowledge with other members of the group or company to increase internal intelligence.Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.Support training and qualification of other auditors.Business title: Principal Scientist-Quality Auditor - GQAAC
Minimum Requirements:
Relevant experience(s) (minimum of 5 years) within the GCP medical area at Lilly or within the pharmaceutical environment.Good oral and written communication skills in English.Ability to communicate effectively in Japanese language” in the requirement. Experience working with Third Party Organizations.The ability to understand detailed scientific information, while remaining anchored in the “Big Picture”.Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.Experience working on a global team and sharing knowledge.Experience with computers and entering data into databases.Good analytical/problem-solving skills.Education Requirements:
Bachelors Degree (or equivalent work experience) in physical or biological sciences, engineering or other technical area.
Travel Requirements:
Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 40% (duration 1-2 weeks), sometimes on short notice.
Additional Preferences:
Experience in technical report writing.Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.Proven ability to think and analyze from a process perspective. Project management skills.Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.Work independently as well as collaboratively within a global team environment.Deliver constructive feedback to customers while providing a high level of customer service.Ability to influence and manage change/conflict.Establish and maintain effective working relationships at all levels internal and external to Lilly.Ability to think on your feet and be pragmatic in decision making.勤務地：神戸本社
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
【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“のみ適応
【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。
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
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