Sr. Associate, Quality Management

グローバルな環境で薬品質保証に従事

仕事内容

・Establishes and maintains our Quality Management System.
・Develops, maintains, adheres to, and evaluates systems, processes, policies, and procedures for all quality management activities promoting compliance.
・Manages and reviews all non-QM policies and procedural documents.
・Analyzes results/data to identify areas for improvement in the quality system.
・Updates and disseminates all forms and documents in compliance with relevant laws and regulations.
・Monitors our processes to ensure compliance with regulations, contracting requirements,
and standards and confirms data integrity.
・Manages escalated reports.
・Advises for CRO business, e.g., MSA and CS.
・Develops, implements, and documents internal and external audit processes, which ensure that
all procedures are current and accurate.
・Acts as project manager for QM business process.
・Plans, conducts, reports, and follows up on Internal and Sponsor Audits.
・Confirms CSV
・Conducts GMP, GQP, GLP, GVP, GDP, GDocP audit, GPSP self-inspection, and ICCC process self-
inspection.
・Plans, conducts, and follows up on internal system and project audits (including vendor audits).
・Ensures client audit and regulatory inspection readiness.
・Hosts client audits and regulatory inspections and allocates the corresponding resources to
preparations, the agenda items of explanation, and the documents. Assesses/Reviews the
explanation/documents. Propels the preparation progress.
・Arranges and supports site audits conducted by external providers.
・Supports NDA, e.g., Dossier review, mock inspection, and feedback.
・Manages/Follows up/Closes CAPA Process according to SOP.
・Prepares reports to communicate outcomes of issues.
・Other tasks as deemed necessary by the line manager.

応募条件

【必須事項】

・Bachelor’s degree
・Excellent communication, both written and verbal, and interpersonal skills
・Business level in English is required.
・Many GCP and other GxP audit, regulatory inspection, and Quality lead experiences.
・Proficiency in Office and Adobe Acrobat applications

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

3ヶ月

勤務地

在宅可、東京

転勤の有無

転勤なし

受動喫煙防止措置

屋内原則禁煙（喫煙室あり）

勤務時間

フレックスタイム制
コアタイムあり
　10:00 ～ 15:00

勤務開始日

応相談

休日休暇

年間休日数：120
完全週休2日制
年間有給休暇：　15日 ～ 20日

年収・給与

経験により応相談

諸手当

通勤手当、健康保険、厚生年金保険、雇用保険、労災保険、厚生年金基金

昇給

有

賞与

採用人数

若干名

待遇・福利厚生

通勤手当：無
家族手当：無
寮・社宅：無
住宅手当：無

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
厚生年金基金：有
退職金制度：無

選考プロセス

１）書類選考
２）一次面接
３）最終面接