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Quality

Auditor, Specialist

  • 标题 Auditor, Specialist
  • 功能 Quality
  • 子功能 Quality Assurance
  • 类别 Experienced Analyst, Quality Assurance (P5)
  • 工作地 Mumbai, Maharashtra, India; Taipei, India
  • 发布时间
  • 申请ID 2406191154W
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描述

Role Description

(Please note that a single position may include multiple roles.)

Organization

R&D Quality J&J Innovative Medicine

R&D Quality Group

Quality Assurance - GCP Audits

Role

GCP Auditor

Level
( Scope, responsibilities and ownership will increase with level.)

Specialist

PRINCIPAL RESPONSIBILITIES:

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.

资格

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.

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