Contract: Internship (6 months)
Enterprise
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.
Description
Hemerion Therapeutics is looking for its future Quality Assurance Intern, who will contribute to all the department’s activities.
Location
Hemerion Therapeutics: 37 rue Denis Papin, 59650 Villeneuve d’Ascq, France.
Responsibilities
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.
Qualifications
Student in a regulatory affairs master’s program.
Competence
- Excellent verbal and written communication skills in French and English.
- Dynamic and willing attitude.
- Ability to multi-task autonomously.
Benefits
- Dynamic environment.
- Growing international company.
- Meal voucher.