Senior Quality Assurance Technician
Nuvisan
full-time
Posted on:
Location Type: Office
Location: Biot • France
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Job Level
About the role
- As a member of Quality Assurance, ensure compliance with Good Manufacturing Practices (GMP) for medicines produced at the Nuvisan site and on behalf of clients.
- Perform batch record reviews for the pharmaceutical unit (investigational drug products, marketed products, cosmetics, or medical devices).
- Contribute to the management and follow-up of quality-related events (OOS, deviations, change control, CAPA, product quality complaints, recalls) and inspections/audits.
- Provide support for continuous improvement of quality documentation and offer expertise to operational teams.
- Contribute to the monitoring of the quality management system.
- Support process optimization activities and the ongoing development of quality documentation.
- Contribute to the implementation and operation of quality approach tools and corrective actions resulting from audits.
- Assist in data collection and preparation of key performance indicators (KPIs) for the Quality Assurance activity.
- Conduct self-inspections, internal audits (processes, systems) and participate in external audits (contribute to audit reports, participate in CAPA follow-up plans) in collaboration with a lead auditor.
- Perform individual reviews of documents (plans, protocols, reports, regulatory documents, etc.).
Requirements
- Bachelor's degree (Bac+3) or equivalent, with a specialization in Quality Assurance management.
- At least 5 years of experience in a similar role within a CRO or in the pharmaceutical industry.
Benefits
- With professional experience
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
batch record reviewquality documentationdata collectionkey performance indicatorsself-inspectionsinternal auditsexternal auditsCAPAdeviations managementchange control
Soft skills
compliancecontinuous improvementcollaborationexpertiseprocess optimizationmanagementsupportmonitoringcommunicationproblem-solving
Certifications
Bachelor's degree in Quality Assurance management