Clinical Quality Auditor Job in Officebased In Leipzig
Clinical Quality Auditor
1. FOCUS OF THE JOB
Perform Quality Assurance responsibilities including Internal Audits and Training to ensure consistency and compliance of operations across all Centres.
2. RESPONSIBILITIES
Quality
To produce concise and informative audit reports within defined timescales and follow up with relevant personnel to ensure CAPA implemented.
Investigate Suspected Non-compliances (SNCs) and follow up on internal and external audit findings and SNCs to resolution.
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Act as a key point of contact for staff, providing information and expert guidance on regulations and procedures.
Ensure patient care, well-being and confidentiality remain paramount.
Analyse monitor feedback forms and provide data to internal and external customers.
Maintain performance metrics tools and provide data to internal and external customers
Working as a Team /Communication
Work within the Quality Team promoting best practice.
Maintain relationships with HO and Centre teams globally, providing advice on quality and GCP issues.
Share progress regularly with DQ.
Leadership
Lead audits to completion including corrective and preventative actions
Promote a continuous improvement and "excellence" philosophy across company.
Planning Organising
Prioritise workload for optimum quality and productivity
Plan and conduct site, study, systems and vendor audits and act on findings.
Identify ideas for process improvement and communicate to the DQ.
Professional
Ensure working practices are to internal SOPs and COPS, GCP, regulatory and industry standards.
Present a professional and positive image of company at all times.
Commercial Awareness and Contribution to Targets
Work to achieve targets.
Support centre and head office staff in achievement of company targets.
Identify new quality opportunities and threats.
Confidentiality
Plan work activities to maintain confidentiality.
Ensure confidentiality of staff, patient and sponsor matters.
Maintain all activities as required by Data Protection Act and Good Clinical Practice.
The job description allows for flexibility of development of the role and the post holder will be subject to review of this job description to allow for creative delivery of the role and service. This will be achieved as part of the PDR process.
For further information please contact Sean Sutton Progressive Munich S-Three