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Auditor, Specialist

  • Título Auditor, Specialist
  • Función Quality
  • Sub función Quality Assurance
  • Categoría Experienced Analyst, Quality Assurance (P5)
  • Ubicación Mumbai, Maharashtra, India; Taipei, India
  • Publicado
  • Identificación requerida (Req ID) 2406191154W
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Role Description

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


R&D Quality J&J Innovative Medicine

R&D Quality Group

Quality Assurance - GCP Audits


GCP Auditor

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



Main responsibilities will include but are not limited to:


·       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.

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