QA Specialist conducting client evaluations and developing service plans in the home care sector. Responsible for supervising staff and ensuring compliance with regulations, with duties involving field visits and documentation.
About the role
- Senior Quality Assurance Technician overseeing good manufacturing practices for pharmaceuticals at Nuvisan. Reviewing batch records and supporting quality management activities.
Responsibilities
- 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
Job title
Job type
Experience level
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Degree requirement
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