職種・勤務地・キーワードで探す
条件を変える
コンプライアンスの求人359件応募資格・募集要項・仕事内容を見る
Specialist Quality Assurance – Innovative Medicine
- 給与
- 記載なし
- 勤務地
- 記載なし
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
Leads the planning, conduct and reporting of R&D Quality QA routine audits and supports non-routine audits. Supports regulatory inspections and provides consultation to business partners on routine tasks and compliance inquiries.
この求人に応募
応募資格
必須
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline.
- Minimum 2 years of experience in Pharmacovigilance (PV) within the pharmaceutical or biotech industry.
- Proven hands-on experience in PV operations (e.g., case processing, signal detection, risk management, safety surveillance) or other PV-related roles.
- 2+ years of QA auditing experience, specifically in Pharmacovigilance / GVP audits (internal, external, or vendor audits) is _preferred_.
- Knowledge of Pharmacovigilance regulations and guidelines, including: EU Good Pharmacovigilance Practices and Health Authority requirements in Asian countries
- Individual Case Safety Report management
- Aggregate reporting (i.e. PSUR/PBRER, DSUR)
- Product risk management and implementation of risk minimization activities
- Vendor oversight and PV compliance models
- Experience auditing PV systems, processes, databases, and service providers is _preferred_.
- Strong analytical thinking and attention to detail, particularly in safety data and compliance reviews.
- Excellent communication skills, with the ability to influence and challenge stakeholders constructively.
- Ability to manage multiple audits and priorities in a fast-paced, global environment.
- High level of integrity, professionalism, and objective judgment in sensitive or high-impact audit situations.
- Proven ability to work cross-functionally and across geographies.
歓迎
- Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
募集要項最終確認 10/22
- 職種
- コンプライアンス
- 雇用形態
- 記載なし
- 給与
- 記載なし
- 勤務地
- Petaling Jaya, Selangor, MalaysiaBeijing, ChinaChiyoda, Tokyo, JapanMumbai, Maharashtra, IndiaShanghai, ChinaSingapore, SingaporeTaguig, National Capital Region (Manila), Philippines
- 働き方
- 記載なし
- 経験年数
- 2年以上
- 学歴
- 大学卒業以上
- 掲載日
- 2026/10/19 15:02（4日前）
- 最終確認
- 2026/10/22 21:50（1日前）
仕事内容
Job Description
- Main responsibilities will include but are not limited to:
Auditing
- Leads the planning, conduct and reporting of R&D Quality QA routine audits and supports non-routine audits of activities, data, internal facilities and processes in GxP/non-regulated areas to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
- Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
Inspection Support
- Supports regulatory inspections in various supporting roles.
Training & Development
- Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
- May assist in the preparation of training material if requested.
People Management
- N/A
Project Management
- Participates in projects or serves on teams, as assigned by supervisor.
- Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
Subject Matter Expert / Point of Contact
- Provides consultation to business partners on routine tasks with occasional supervision. Cooperates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.
この求人は、ジョンソン・エンド・ジョンソン株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
募集元の採用ページから応募できます
応募はジョンソン・エンド・ジョンソン株式会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。