Quality Assurance Engineer

Dynamic SME attached to the Sinclair Group, **Laboratoire Sinclair France** specialises in the design, manufacture and marketing of medical devices based on cross-linked hyaluronic acid for use in aesthetic medicine.

Sinclair has acquired the product Lanluma produced in Korea by Gana. Sinclair France has been designated to be the Legal Manufacturer of Lanluma.

As part of a job creation, Laboratoire Sinclair France would like to recruit the services of a Quality Assurance Engineer to manage the subcontracting site of GANA and acts as the representative of the legal manufacturer.

**Responsibilities and Accountabilities of the Role**:
Activities related to Quality Management system
- Maintain a close follow-up on subcontracting activities
- Manage the subcontracting contract with GANA
- Perform audit of the contract manufacturing site, log audit NC in the Corporate system and ensure follow up of the CAPA plan in collaboration with Gana
- 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 in collaboration with Gana
- Ensure change control assessment, log of change controls in the Corporate system and ensure follow up of the CC plan in collaboration with Gana

Activities related to Regulatory Affairs
- Technical support to Sinclair's 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 relating to Lanluma products

Activities related to Materiovigilance
- Participate in the handling of customer complaints and materiovigilance cases in collaboration with the Quality and Corporate Vigilance Sinclair departments and with Gana for investigations
- Participate in the validation of security measures in collaboration with Corporate Sinclair
- 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 in collaboration with Corporate Sinclair and ensure that appropriate corrective and preventive actions are implemented

Activities related to Risk Management
- Review of the QMS risk management process from GANA
- Participate in product risk management activities in collaboration with Corporate Sinclair

**Experience and Qualifications**

Essential:

- Expertise in lyophilisation process
- 4/5 years' higher education in a scientific and/or quality control field.
- 4 years’ experience in the medical device, pharmaceutical or biotechnology industries and/or a physical chemistry quality control department.
- Fluent English (written and spoken)
- Good command of IT tools (Word, Excel)
- Based closed to Lyon or agree to move close to Lyon

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

General competencies:

- Teamwork
- Taking the initiative
- The search for continuous improvement

Status: Cadre

Pay: 50,000.00€ - 52,000.00€ per year

**Experience**:

- lyophilisation: 1 year (preferred)

Work Location: In person