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Main responsibilities will include, but are not limited to:
• Independently leads the planning, conduct and reporting of BioResearch QA routine and non-routine audits/assesments/inspections of activities, data, internal facilities and processes in GxP/non-regulated 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. Manages complex or business critical audits/issues in a supporting or leading role. Supports other auditors in planning, conduct and reporting of audits. Conducts Peer review of audit reports. Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
• Participates in regulatory inspections in a leadership role (e.g. host, backroom lead)
Training & Development
• Identifies training needs. Develops and provides training. Independently advises and coaches other auditors.
• Completes training requirements in a timely manner to ensure inspection readiness at all times.
• Able to supervise junior auditors/contractors and deputises for Team Lead, as required.
• Leads initiatives and actively participates in key projects. Interacts with key stakeholders and is able to influence and effectively drive projects to completion.
Subject Matter Expert / Point of Contact
• Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders.
• Independently provides consultation and advice to Business Partners and the core business sector on quality and compliance processes/procedures.
• Interprets and applies regulations/policies to unique and/or complex issues, when required.
J&J (China) Investments Ltd (7046)