Quality Control - Lab Analyst

主な業務内容

Main Responsibilities

• 試験室の安全環境の整備し、EHSインシデント、EHS指摘事項を低減する。
  Improve the safety environment of the laboratory and reduce EHS incidents and observations.
• EHS遵守向上のための改善、戦略を提案し、EHSリスクアセスメントをリードする。
  Propose improvements and strategies to improve EHS compliance and lead EHS risk assessment.
• 分析者が定められた品質要件を遵守して試験業務を行っていることを確認する。
  Make sure that the analysts perform the testing in compliance with the specified quality requirements.
• 必要に応じ、受入試験、出荷試験、安定性試験、バリデーション関連試験等を実施する。
  Conduct incoming, release, stability, and validation-related tests, etc. as necessary.
• 試験責任者として、データの信頼性を保証し、確認、承認を行う。
  As the responsible person for testing, ensure, confirm the testing data.
• 課内のリスクを特定し、報告する。
  Identify and report risks in laboratory operation section.
• 改善プロジェクト（GPS等）をリードし、効果的かつ効率的に試験を実施するためのアクションを推進する。
  Lead improvement projects (GPS, etc.) and promote actions to conduct tests effectively.
• 関連業務（LSOP/WI改訂、標準品のOrder,　OOT/OOS調査、機器点検、RCA/CAPA等）を実施する。
  Carry out laboratory related tasks (LSOP / WI revision, Ordering Reference Standard, OOT / OOS survey, equipment inspection, RCA / CAPA, etc.).
• 品質試験に関するトラブルシューティングに対応する。
  Respond to trouble shooting for laboratory testing.
• 当局及び関連査察に対応する。
  Respond to regulatory and external audits/inspection.
• 上司の指示により、必要な業務を実施/サポートする。
  Carry out / support necessary work according to the instructions of your boss.
• 新製品の技術移管を海外のDonorサイトと協議しながら進め完了、日本市場へ出荷するルーチン試験への落とし込みを行う。
  Carry out Analytical Technical Transfer for new product with Oversea donor site/function, and implement to routine release testing for Japan Market.

スキル及び経験に応じて、上記のすべてあるいは一部の業務を行って頂きます。

We will ask candidates to conduct all or part of responsibilities listed above based on skill and experiences.

※職務内容および勤務地の変更範囲は会社の定めるところとする。


必要な条件
Required

スキル Skill

• GMP、QMS、薬事及びEHSにおける知識
  Knowledge of GMP, QMS, regulatory, and EHS
• 分析機器及びコンピュータ化システムに関する知識
  Knowledge of analytical equipment and CSV
• 分析技術及びData Integrityに関する知識
  Knowledge of analytical technology and data integrity
• Data Integrityに関する基本的な認識
  Basic understanding of data integrity
• 積極的なCommunication Skill
  Proactive communication skills

経験 Experience

• 品質管理業務に3年以上従事した経験
  Over 3 years of experiences in quality control

学位/資格/語学力 Degree/Qualification/Language capability

• 薬学、化学、生物、工学、理学、農学系の学士以上
  University degree or higher of sciences (pharmacy, chemistry, biology, engineering, agriculture)
• 英語でのコミュニケーション（読解、メール、日常会話）
  Communication in English (Reading, email, daily conversation)

望ましい条件
Preferred

スキル Skill

• 生産管理システム（SAP）に対する知識
  Knowledge of SAP production management systems
• 根本原因特定、問題解決、業務改善能力
  Ability in root cause analysis, problem solving, and process improvement ​
• 継続的改善に関する知識、意欲
  Knowledge of and strong motivation for continuous improvement

経験 Experience

• 製薬工場での業務経験
  Experiences in pharmaceutical factory

学位/資格/語学力 Degree/Qualification/Language capability

• 理系（薬学、化学、生物、工学、農学）修士卒以上
  Master degree or higher of sciences (pharmacy, chemistry, biology, engineering, agriculture)
• 英語でのコミュニケーション（電話会議参加）
  Communication in English (Conference call)

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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