Clinical QA Specialist/Manager
A leading biotechnology company is advertising a vacancy for a Clinical QA Specialist/Manager, to be based in their German office. The organisation focuses on developing first-in-class drugs for the treatment of chronic diseases. This is an exciting opportunity to work with an innovative company provide real expertise in the QA field.
- Primarily focusing QA/QC within the ongoing and planned clinical trials.
- Conducting audits of clinical sites and vendors (laboratories, data management and biostat, and IMP logistics).
- Performing QC within the trials, including TMF review, quality visits, and QA releases per SOPs.
- Participating in the development and implementation of the QMS of the company with focus on Clinical Development area, including SOPs management, audits planning and reporting, vendors qualification and oversight, CAPAs management risk management, change control, etc.
- Supporting clinical operations in daily activities, providing trainings, and serving as subject matter expert for other departments.
Skills and Requirements:
- Demonstrable experience in a similar or related role.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Antoine Mortiaux at email@example.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.