GCP / GVP Quality Specialist

GCP / GVP領域におけるQMS / QA強化のため

QMS業務

GCP / GVPに対する包括的なQMSのプロセス / デジタル化戦略を策定し、グローバルレベルでその推進を行う

GCP / GVP領域のQMS戦略を立案・実行し、その効果を評価しながら、継続的な改善を行う

GCP / GVP規制等の最新動向を把握し、QMSの運用を強化するための持続的な改善活動を実施する

Global Process Owner Network等のQMS活動やQAガバナンスを継続的に改善する

QA業務

GCP / GVP監査による国内外規制要件および社内規定の遵守状況の確認に基づくQuality Management System(QMS)改善提案とCAPA Planのレビュー?を実施する

GCP / GVPの査察対応業務（Inspection Lead）を通じて、規制当局、またはパートナー監査者からの複雑な問合せに対応する?

GCP / GVP領域における複雑な問合せに対する規制要件、社内規定に基づいたコンサル業務?を実施する

Quality業務担当者とのコラボレーションを通じて幅広いQMS / QA業務への理解が深まり、継続的改善に生かすことができる

PV領域とGCP領域のQMS / QA活動を実施しているため、GxP俯瞰的な高い視座に立った活動ができる

Background of recruitment：

For the enhancement of QMS / QA in the GCP / GVP domain

Description of work :

Depending on suitability, you will be assigned for one of the following tasks :

QMS tasks

Formulate comprehensive QMS processes / digital strategies for GCP / GVP and promote them at a global level

Plan and execute QMS strategies in the GCP / GVP domain, evaluate their effectiveness, and continuously improve them

Keep up with the latest trends in GCP / GVP regulations and implement continuous improvement activities to strengthen QMS operations

Continuously improve QMS activities and QA governance through committees and the Global Process Owner Network

Develop plans to achieve promised results in line with team and department goals

QA tasks

Propose improvements to the Quality Management System (QMS) and review CAPA Plans based on the compliance status with domestic and international regulatory requirements and internal regulations through GCP / GVP audits

Respond to complex inquiries from regulatory authorities or partner auditors as GCP / GVP Inspection Lead

Provide consulting services based on regulatory requirements and internal regulations for complex inquiries in the GCP / GVP area

Position Features

Deepen understanding of a wide range of QMS / QA tasks through collaboration with various Quality task personnel and utilize it for continuous improvement

Engage in QMS / QA activities in both PV and GCP domains within the same organization, allowing for high-level activities from a GxP perspective

Improve advanced regulatory response capabilities in Europe and the US by working in a global field

Strengthen wide networking and communication skills through collaboration with internal and external, domestic and international customers and stakeholders 応募資格／Qualifications 求める経験：

GCP又はGVPにおける実務経験（3年以上）

SOP維持管理、CAPA対応）

QMS改善・CAPA構築を支援できるスキル・知識

GCP / GVPに関する国内外規制及び専門的知識

QMSの更なる向上のために、関係各所と協業しながら、適切な対応ができる

TOEIC 730点以上 / CEFR B2以上または同等のビジネス英語スキル

N2レベル以上または同等のビジネス日本語スキル

IRCA認定ISO9001准審査員系資格があればなおよい

Desired experience：

Practical experience in GCP or GVP (3 years or more)

Quality management tasks (SOP maintenance, CAPA response)

Audit / inspection experience

Experience working with overseas affiliates (customers)

Desired skills / knowledge / abilities：

Skills and knowledge to support QMS improvement and CAPA development

Specialized knowledge for domestic and international regulations related to GCP / GVP

Desired competencies：

Promote constructive discussions and collaborate with members even in situations of conflict or confrontation, positively influencing other members

Respect each other's positions, listen to stakeholders' opinions, discuss openly, respond flexibly and persistently, and pursue results while gaining stakeholders' understanding

Demonstrate leadership in addressing cross-organizational issues, involving stakeholders and working as one team to solve problems

Catch up with changes in the uncertain external environment, respond appropriately without fear of change, and collaborate with relevant parties to further improve QMS

Desired Qualification：

TOEIC 730 points or higher / CEFR B2 level or equivalent business English skills

if Japanese is not your native language) Japanese Language Proficiency Test N2 level or equivalent business Japanese skills

IRCA certified ISO9001 provisional auditor qualification is preferred 待遇／Salary & Benefits 労働条件の通知は電子ファイルによって行います。

The notification of working conditions will be made in an electronic file.

If you apply, please understand this point.

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