This job position is for a GCP medical auditor. The position is office-based located at the Lilly Kobe affiliate office.
Position Brand Description:
The Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through the execution of internal and external audits in support of pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance and consumer information quality (CIQ) for Lilly. Through auditing, the Global Quality Auditor assures that GXP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations, applicable guidelines and industry standards.
GQAAC is operating as a valued business partner and taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance. The Quality Auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight.
Key Objectives/Deliverables:
The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:
Auditing:
Scheduling, preparing, conducting and reporting GQAAC audits and assessments of GXP operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.
Participate in or lead the risk assessment of GXP operations in support of generating the GQAAC risk-based annual audit plan.
Appropriately escalate any compliance issues.
Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
Global Quality – Business Related Responsibilities:
Participate in or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.
Participate in or lead the preparation of organizational metrics and trending of audit findings, when required.
Provide audit-related advice to GXP operations on the interpretation of corporate and regulatory GxP requirements (standards/policies/procedures) related to quality management, when required.
Establish and maintain relationships with relevant business areas and regulatory authorities, including support for regulatory inspections, when required.
Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.
Personnel Development:
Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
Complete required training for the roles identified in the Individual Training Plan (ITP)
Be continually aware of current industry trends and regulatory agency interpretation of GxP requirements.
Seek self-development in GxP areas (e.g. attend training courses, conferences or association meetings) and share such information and knowledge with other members of the group or company to increase internal intelligence.
Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.
Support training and qualification of other auditors.
Business title: Principal Scientist-Quality Auditor - GQAAC
■休日：完全週休二日制, 年末年始
