Auditeur Assurance Qualité H/F
On-siteLyon, Auvergne-Rhône-Alpes, France
Lyon, Auvergne-Rhône-Alpes, FranceOn-siteFull TimeSenior LevelLarge
Full TimeSenior LevelLarge
Job Summary
Conduct protocol, experiment, raw data, and report audits in compliance with BPL/GLP, BPF/GMP, and COFRAC ISO 17025 standards. Prepare and communicate quality indicator data, update quality documentation, and support client and regulatory audits. Manage non-conformities, CAPAs, and complaints by collecting evidence, identifying root causes, and validating corrective actions. Lead internal audits, draft audit reports, and train staff on quality procedures. Join NAMSA, a global leader in medical device safety, to contribute to continuous improvement projects and product development cycles.
Required Qualifications
- Bac +2 / Licence in Quality
- Bac +2 / Licence in natural or technical sciences
- Background in the pharmaceutical industry
- Background in a similar domain to the pharmaceutical industry
- Knowledge of regulatory requirements specific to the medical device industry
- Analytical skills
- Diligence
- Problem solving skills
- Good interpersonal skills
- Teaching skills
- Collaboration skills with other departments
- Fluency in the local language
- Level B1 of English
- Knowledge of MS Office applications
- Experience with MS Office applications
- Ability to write and review complex documents
- Ability to update Quality documents
- Ability to prepare and communicate data for Quality indicator tracking
- Ability to support client and regulatory body audits
- Ability to participate in management reviews and associated meetings
- Ability to participate in quality system improvement projects
- Ability to participate in continuous improvement and remediation projects
- Ability to plan, execute, and follow up on protocol, experimentation, raw data, and report audits
- Ability to plan, execute, and follow up on internal audits
- Ability to write audit reports
- Ability to follow up on corrective actions
- Ability to manage deviations, non-conformities, CAPA, and complaints
- Ability to collect, record, and search for root causes of non-conformities
- Ability to evaluate risks
- Ability to finalize corrections
- Ability to implement corrective actions
- Ability to implement preventive measures
- Ability to validate final actions
- Ability to follow up with staff and management on workflow management
- Ability to implement and follow up on document automation
- Ability to train staff on quality procedures
- Knowledge of BPL/GLP standards
- Knowledge of BPF/GMP standards
- Knowledge of COFRAC ISO 17025 standards
Desired Qualifications
- Bac +2 / Licence in Quality (preferred)
- Background in Laboratory Science
- Background in Clinical Research
- Background in Regulatory Affairs
- Background in Engineering
- Background in Sales & Business
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.