Contract: Internship (6 months)
Hemerion Therapeutics is a clinical-stage healthcare company. The company is the result of over 10 years of academic and clinical research dedicated to providing innovative approaches to treating glioblastoma. Hemerion possesses a unique and innovative technology which has been evaluated in a first-in-man clinical trial for the treatment of this brain cancer.
Hemerion Therapeutics is looking for its future Quality Assurance Intern, who will contribute to all the department’s activities.
Hemerion Therapeutics: 37 rue Denis Papin, 59650 Villeneuve d’Ascq, France.
Under the supervision of the Regulatory Affairs Manager and the Quality Assurance Manager, the intern takes part in the following activities
- Participate in Implementation of the QMS activities according to the requirements of 21 CFR 820, ISO 13485:2016, the ICH Q10 and other applicable regulation to product realization.
- Participate in the management of document control activities according to the FDA and international regulations ensuring that all document changes are processed and approved according to the standard operating procedures.
- Participate in the preparation in achieving its ISO 13485:2016 certification.
- Participate in the management quality records including device history records, QA records, test reports, manufacturing records, and equipment records.
- Participate in performing incoming inspections, final product release inspections, and preliminary product failure investigation/testing as a part of CAPA process.
Student in a regulatory affairs master’s program.
- Excellent verbal and written communication skills in French and English.
- Dynamic and willing attitude.
- Ability to multi-task autonomously.
- Dynamic environment.
- Growing international company.
- Meal voucher.