お仕事情報

お仕事情報

Senior Quality Assurance Auditor:SS-3522MY

  • 外資系企業
  • 女性が活躍
  • 英語を活かす

世界トップのグローバル・ヘルスケア アウトソーシング企業

求人コード SS-3522MY
募集職種 Senior Quality Assurance Auditor
職務内容 ・Plan, schedule, conduct, report and close audit activities in any of the countries involved with our contracts.
Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, our SOPs and project specific guidelines/instructions.
・Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
・Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
・Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
・Prepare and review and approve corrective action plans
・Present educational programs and provide guidance to operational staff on compliance procedures.
・Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
・Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
・Host customer audits,
・Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed.
・Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.
・Act as subject matter expert (SME) in developing solutions, enhancing, and supporting the SOP management program and identifying the long- term SOP Management strategy and requirements.
Develop effective business partner relationships in support of SOP Management objectives.
・Consult, review, edit, standardize, or revise material prepared by others. Produce or arrange illustrations, charts, flow diagrams to be included in documents. Prepare layout of material for documents.
・Prepare/write technical documents related to SOP Management systems/applications for review by staff and / or customers.
応募要件 ・5 years+ experience in pharmaceutical, technical, or related area, of which 3 years+ in Quality Assurance;
GxP experience
・Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
・Knowledge of quality assurance processes and procedures.
・Strong interpersonal skill
・Excellent communication skills in Japanese/ English
・Excellent problem solving, risk analysts and negotiation skills.
勤務地 東京
年収 800万円~1000万円
最終学歴
推奨される資格要件
その他 【給与】経験・能力・資格等考慮し、弊社規程に則して決定します。
【昇給】 年1回(4月)
【賞与】 年2回(6月・12月)、業績賞与(3月)
【諸手当】 時間外手当、通勤手当、外勤手当(CRA職等)
【勤務時間】標準勤務時間9:00-17:30(1日標準7.5時間)/フレックスタイム制(コアタイム/11:00~15:00)、在宅制度(週2回)
【休日休暇】完全週休2日制(土・日)、祝祭日、年末年始(12/29~1/4)、有給休暇、病気休暇、慶弔休暇、女性特別休暇、長期特別休暇
【福利厚生】各種社会保険完備、退職金制度、総合福祉団体定期保険制度、長期収入補償制度、財形貯蓄制度、福利厚生倶楽部、EAP等

※ 契約社員の場合は一部異なりますので、ご応募頂いた際に個別にご説明致します。

オンライン登録のご案内

ライフケア・ネットワークではオンライン登録フォームをご用意しています。
ご記入頂きますと、自動的に当社履歴書フォーマットで登録となります。
本サイトへ掲載されていない求人・非公開求人も多数ございます。是非一度ご登録下さい。

オンライン登録(無料)

ページトップ

Copyright © e-製薬 All Rights Reserved.