QA Officer GCP (m/f)

REFERENZNUMMER:

299929/1

IHRE AUFGABEN:

-Develop and support the implementation of a GxP compliant Quality Management System (QMS), as well as actively participate in the development of GCP compliant Quality Management System (QMS)
-Maintain and continuously improve the quality management system to support clinical studies and to ensure compliance with Good Clinical Practice (GCP) and local regulatory requirements
-Develop audit plans to ensure all clinical trials are conducted in compliance with the study protocol, site procedures, and all applicable regulatory requirements
-Conduct audits of clinical sites, clinical quality systems, clinical vendors, sponsor and regulatory documents to ensure clinical trials are conducted per Good Clinical Practice (GCP) requirements
-Assist in the development of metric reports to QA management of all issues related to the outcome of the audits
-Support the establishment and maintenance of the QMS and quality standards, to assess compliance with GxP principles
-Verify and support GxP compliance of computerized system validation and change control according to established regulations and guidelines such as GAMP5 and 21CFR11
-Create and advise on and support the establishment and continual improvement of Standard Operating Procedures and Work Instructions

IHRE QUALIFIKATIONEN:

-Master’s degree in Engineering or Life Sciences
-Substantial practical experience in quality assurance within a GxP industrial environment such as Pharmaceuticals, Medical Devices, Biotech or Food, as well as an excellent working knowledge/understanding of International Conference on Harmonization (ICH) Q8, Q9, Q10 and of GCP related requirements, including proficiency in US regulations and ICH guidelines for the conduct of clinical trials
-GCP knowledge/clinical development background required
-Fluent in in both written/spoken English (proficiency in French would be an asset)

WEITERE QUALIFIKATIONEN:

Quality manager