GMP監査対応（PMDA,FDAなど）の求人一覧

JSOX業務や業務企画など含め内部監査室の業務を担っていただきます。

仕事内容

SOX業務
・全社統制、決算財務報告プロセス、業務プロセス、IT統制（全般統制及び業務処理統制）を担当
・内部監査業務【リスク評価／監査計画／監査実施改善提案/フォローアップ】
・業務企画／推進 ※上記について,スキルや経験に応じてご担当していただきます。

応募条件

【必須事項】

管理系業務のご経験

【歓迎経験】

JSOXまたは内部監査のご経験

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】大阪

年収・給与

400万円～700万円　経験により応相談

請負業者に対する独立した客観的なGxP監査を実施し、各拠点のコンプライアンスおよび業界規制・事業上の期待事項への準拠状況に関する評価を提供

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.

応募条件

【必須事項】

・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.

【歓迎経験】

【免許・資格】

Although none were required. Auditing Certification preferred (either by an independent body or by a corporate program).

【勤務開始日】

応相談

勤務地

【住所】在宅可、東京

年収・給与

950万円～1250万円