募集職種

管理者・施設長  

雇用形態

正社員

仕事内容

・To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.  Perform GxP internal and external audits based on a defined audit plan within specific time constraints, including the facilitation of opening and closing audit meetings with all levels of Management, the preparation of all associated documentation, including audit plans and audit reports under strict confidentiality, and track and monitor audit responses and the implementation of corrective and preventative actions.  Review audit reports for accuracy and consistency as related to cGMP regulations, guidance documents and internal standards, and recommend clarifications, corrections, and provide final approval for audit reports before issuance.  Provide guidance and support in the development of corrective and preventative actions based on GxP regulations, guidance documents and current industry standards.  Review corrective action responses for accuracy and consistency as related to cGMP regulations, guidance documents and internal standards. Recommend clarifications, corrections, and provide final approval for corrective actions submitted to remediate a company's audit.  Serve as a liaison between GOA and internal sites/functions, and provide them with support via vendor auditing for their supplier management processes.  Perform independent research and provide interpretation of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (GxP and ICH), including assessment of applicability and impact on systems being audited.  Author and approve Quality Compliance procedures with the GOA function, and provide guidance to internal sites/affiliates as required to ensure local procedures meet GOA governance documents and Global Quality Policies.  Plan, schedule, and arrange travel to various sites based upon guidance from Management.  Perform other duties as assigned.

給与

正社員：年収 9,500,000円〜12,500,000円

給与の備考

年収　　950万円～1250万円

待遇・福利厚生

通勤手当：有 在宅勤務手当(出社日数による）退職金制度（確定給付企業年金制度、確定拠出年金制度）、ベネフィットプログラム（総 合福祉団体定期保険、団体傷害保険、団体長期障害所得補償保険、保育・介護施設補助、傷病見舞金、 災害見舞金、等）、リスキリング費用サポート、健康管理プログラム

試用期間

3ヶ月

勤務時間

フレックスタイム制 フルフレックス（コアタイムなし） フレキシブルタイム：5：00～22：00

休日

年間休日数：123 土日祝 年間有給休暇：　 ～ 20日 法定休暇：年次有給休暇、産前産後休暇、介護休暇 その他休暇：慶弔 休暇、ライフサポート休暇（傷病・ファミリーサポート休暇）チャイルドケア休暇、ボラ ンティア休暇、育休特別休暇、リスキリング休暇　等

応募要件

・The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required. ・Minimally Science, Pharmacy, Engineering, or related technical discipline with at least 10 years of experience in Product Quality Assurance. Three to five years of direct cGMP compliance auditing experience is desired. ・ Thorough knowledge of pharmaceutical cGMPs and global governmental regulations, including PMDA, US FDA, ICH and EMA. ・Have familiarity with national and international cGMP regulations, guidelines and expectations in multiple pharmaceutical dosage forms. Knowledge of consumer product and medical device regulations is desired. ・Demonstrated ability to communicate with and to influence others is essential. ・ Ability to work with colleagues at every level to communicate ambiguous concepts. Ability to present to groups across the organisation. ・ Demonstrated personal leadership, accountability, and organisational skills with proven ability to operate independently with minimal supervision. 語学力： Ability to read and interpret complex business and/or technical documents (in English and Japanese). Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors to communicate ambiguous concepts. Ability to present to groups across the organization. Ability to understand technical documents and communicate a description of potential problems and/or solutions.

最終更新日：2026/7/16

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