Description
Profil :
University Degree in Health Sciences or similar educational background
Previous experience in Quality Assurance in the pharmaceutical industry with a focus on Clinical Development activities, or experience in Clinical Development with solid knowledge of Quality Assurance requirements and processes
Good understanding of GCP (Good Clinical Practices) requirements
Bringing an initial experience in Health Authorities Inspections / GCP audits would be a strong asset
Fluent in English (written and spoken), with, ideally, good oral skills in French
Task :
Ensure timely management and execution of risked based Clinical audit programs (internal and external)
Assist inspection readiness of Clinical, Regulatory and Medical processes
Assist the development of Quality Risk Management Plan for Preclinical / Clinical, Pharmacovigilance, Regulatory and Medical activities according to Corporate Risk Management Plan
Support Preparation, hosting and follow up activities of GCP/GVP Regulatory Inspections
Manage of Quality Issues in the field of clinical/pharmacovigilance operations
Ensure compliance to current Good Clinical Practices through Quality oversight and guidance in your area of operations
To cover a maternity leave within our Quality Management teams, we are recruiting a Clinical Quality Assurance Specialist based at our headquarters and production site in Geneva, for a 6-months fixed-term contract starting ideally in August 2024. Reporting to the Clinical & Pharmacovigilance QA Senior Manager, your mission is to support our clinical operations plan from a Quality Assurance standpoint, by giving guidance, mitigating risks, and solving quality/compliance related issues.
You describe yourself as a dynamic and methodical person, who enjoys taking high attention to details and brings excellent organizational skills. Thanks to your communication and interpersonal skills, you know how to establish collaborative links with cross-functional teams and external stakeholders. Finally, you are a critical thinker, and you feel comfortable in a position where you make recommendations and take initiatives to move things forward.
Application : https://careers.ompharma.com/job/Meyrin-Clinical-Quality-Assurance-Specialist-Limited-%286-months%29-Geneva-Gene/1087684101/