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J&J Family of Companies Auditor, Specialist in Maharashtra, India

Auditor, Specialist - 2406191154W

Description

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.

Qualifications

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.

Primary Location Asia Pacific-India-Maharashtra-Mumbai

Other Locations Asia Pacific-Taiwan-Taipei-Taipei

Organization Johnson & Johnson Private Limited (8080)

Job Function Quality Assurance

Req ID: 2406191154W

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