About this role
At Johnson & Johnson, health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Through expertise in Innovative Medicine and MedTech, we innovate across healthcare solutions to profoundly impact health for humanity.
The Senior Specialist Quality Assurance Auditor independently leads planning, conduct, and reporting of R&D Quality QA routine and non-routine audits in GxP. This includes due diligence, for-cause audits, and complex system/service provider audits to ensure adherence to corporate policies and regulatory requirements. Manages complex or business critical audits in a leading or supporting role.
Johnson & Johnson provides an inclusive work environment where each person is considered as an individual. We respect the diversity and dignity of our employees and recognize their merit, guided by Our Credo. Employees work across global locations including Singapore, Bangkok, Jakarta, and Petaling Jaya.
Assists in preparation and delivery of training materials, advises on coaching, and completes training for inspection readiness. Takes active roles in projects, interacts with stakeholders, and provides expertise on quality and compliance processes. Interprets regulations and policies for issues of moderate complexity.
Requirements
- Business Alignment
- Coaching
- Collaborating
- Compliance Management
- Continuous Improvement
- Fact-Based Decision Making
- Good Manufacturing Practices (GMP)
- Quality Management Systems (QMS)
Responsibilities
- Independently leads the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes in GxP
- Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
- Participates in regulatory inspections in core and supporting roles
- Assists in preparation and delivery of training materials and advises and contributes to coaching
- Completes training requirements in a timely manner to ensure inspection readiness at all times
- Takes an active role in projects as assigned by supervisor and interacts with key stakeholders
- Meets priorities, checkpoints and timelines for all aspects of work and projects
- Provides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures
Benefits
- Inclusive work environment where each person is considered as an individual
- Respect for the diversity and dignity of employees
- Recognition of employee merit guided by Our Credo
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