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Auditor, Specialist

3 months ago

Mumbai, Maharashtra, India Johnson and Johnson Full time

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 Role 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.
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.