Quality Assurance Engineer

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