Quality Assurance Engineer
Infos sur l'emploi
- Date de publication :19 septembre 2024
- Taux d'activité :100%
- Type de contrat :Durée indéterminée
- Télétravail :Possible
- Lieu de travail :rue du petit chene, 1000 Lausanne
Pour notre client une entreprise du medical device nous recherchons un/e
Responsibilities
Activities related to Quality Management system
· Maintain a close follow-up on subcontracting activities
· Perform audit of the contract manufacturing site, log audit NC in the Corporate system and ensure follow up of the CAPA plan
· Review and approval of the process and product validation protocols and reports (manufacturing process, sterile barrier, stability,…)
· Ensure production non conformity assessment, log of the NC and CAPA in the Corporate system and ensure follow up of the CAPA plan
· Ensure change control assessment, log of change controls in the Corporate system and ensure follow up of the CC plan
Activities related to Regulatory Affairs
· Technical support to client Regulatory Affairs and Corporate Vigilance department for the maintenance of approvals and registration certificates of Lanluma products
· Prepare for and support in regulatory audits and inspections
· Conformity verification and approval of EC declarations of conformity and technical documentation
Activities related to Materiovigilance
· Participate in the handling of customer complaints and materiovigilance cases in collaboration with the Quality and Corporate Vigilance departments
· Participate in the validation of security measures
· Review and approval of materiovigilance reports prior to submission to the authorities
· Review and approval of declarations and safety measures submitted to the authorities: Field Safety Notice, Field Safety Corrective Action, recalls/batch withdrawals.
· Participate in post-trade surveillance activities and ensure that appropriate corrective and preventive actions are implemented
Activities related to Risk Management
· Review of the QMS risk management process
· Participate in product risk management activities
Experience and Qualifications
Essential:
· 4/5 years' higher education in a scientific and/or quality control field.
· 4 years’ experience in the medical device, biotechnology industries quality control department.
· Fluent English (written and spoken) French
· Good command of IT tools (Word, Excel)
Desirable:
· At least 1 years’ experience in the field of injectable products
· Knowledge of the Medical Device Regulation 2017/745
Job Competencies
Role competencies:
· Knowledge of Lyophilisation
· Knowledge in Audit process
· Knowledge in NC/CAPA process
· Knowledge in Change Control process
· Knowledge of Medical Devices regulations (MDR 2017/745)
· knowledge of pharmaceutical standards
Contact
- Écrire un email