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| 部署・役職名 | GMP Auditor |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
【概要】 Conduct independent and objective audits of internal GxP systems and/or external suppliers/contractors to provide executive management a point in time assessment of a site’s compliance and adherence to industry regulations and business expectations that will be utilized to mitigate risk, enhance compliance, foster improvement and align with regulatory requirements. 【詳細】 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. 1. Participate and/or lead internal site or external supplier/contractor audits, as required, based upon areas of expertise. 2. Perform independent research of FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational （GxP and ICH） regulations and guidance documents including assessment of applicability and impact on systems being audited. 3. Provide independent review, comprehension, and discussion of departmental, regional and global policies and procedures with multiple levels of employees and Management. 4. Provide interpretation of complex regulations and guidance documents through research of current regional, global and governmental expectations. 5. 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. 6. Provide guidance and support in the development of corrective and preventative actions based on GxP regulations, guidance documents and current industry standards. 7. Author and approve procedures. 8. Serve as a compliance reference regarding GxP Interpretations for all levels of Management. |
| 労働条件 | 同社では全面禁煙となっており、採用も非喫煙者の方が対象となっております。 |
| 応募資格 |
【必須（MUST）】 ・Minimum of 4 years relevant GMP experience. （Audit）・English: More than business level 【求める人物像】 ・Ability to solve problems with complex variables through non－standardized solutions that require independent judgment and analysis. ・Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/03/25 |
| 求人番号 | 3397117 |
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- 会社規模501-5000人
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です