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Clinical Research - Quality Assurance Auditor Jobs - Germany

Job Description

Flame Pharma Clinical Research Jobs - Quality Assurance Auditor Jobs - Germany

Flame Pharma is currently working alongside a leading global solutions-driven CRO that deliver clinical trial services of the highest quality for Biopharmaceutical and Medical Device companies. A Quality Assurance Auditor is required in Germany to provide top quality, solutions-driven, specialized outsourced services for the global healthcare community. This opportunity would be ideal for a passionate, talented and imaginative individual with the energy and commitment essential for high performance.

The Role:

As a Quality Assurance Auditor, you will provide auditing and Quality Assurance activities to guarantee that the systems, processes and performances of the company comply with applicable laws and regulations. You will assist with the maintenance of the global Quality Assurance system alongside with assisting in the provision of Quality Assurance reviews of SOP’s prior to approvals and you will be involved with the input into process improvement initiatives. Auditing activities will include organising, leading and participating in contrast and internal audits across global operations. You will assist in the training, liaison and supervision of new or contract auditors as well as providing training to employees on regulatory standards. As a Quality Assurance Auditor, you will work closely with senior management as well as providing a Quality Assurance consultancy for issues raised with personnel. Working alongside Business Development teams may be required in order to represent the client’s services to sponsors and provide input into business planning activities.

The Person:

You will be educated to degree level in health or life science and have relevant experience. Proficiency in auditing databases, trial master files, investigator sites, statistical/clinical study reports, and computer system validation audits is essential as is knowledge of ICH, GCP, FDA code of federal regulations and other applicable regulatory authority laws. Suitable candidates must have experience in hosting and responding to regulatory inspections, possess the ability to investigate and analyse information as well as developing and presenting educational programs. Excellent organisational and communicational skills are paramount alongside MS Office skills.

For more information please apply for this position or alternatively contact Flame Pharma on 0800 085 0858

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