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Clinical Quality Assurance Specialist
Vor 3 Tagen
Meyrin, Geneva, CH
Division: Division: Quality Job Type: Limited-contract
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.
Your main responsibilities are as follows:
- 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 carry out this mission, we are looking for a person with the following profile:
- 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
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.
Are you interested in this opportunity? Apply as soon as possible and join OM Pharma
About Us
OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.
For more information, visit the website: ompharma.com.
AGENCY POLICY About UsOM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: www.ompharma.com
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