外資系製薬メーカー　GCP medical auditor / Principal Scientist-Quality Auditor

資格・要件

Minimum Requirements:
• Relevant experience(s) (minimum of 5 years) within the GCP medical area at Lilly or within the pharmaceutical environment.
　　　（※Relevant experience in GCP medical area including medical quality assurance, medical quality, clinical operations.）
• Good oral and written communication skills in English. 　Ability to communicate effectively in Japanese language.
• 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. ）

職務内容

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.

【その他情報】
契約期間：期間の定めなし
試用期間：6か月
就業場所：兵庫県神戸市
※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・工場・ 海外オフィスでの勤務をする場合もありうる
就業時間：8：45～17：30
※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
時間外手当：支給なし
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
受動喫煙対策：あり　就業場所　全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：有