Quality Assurance Manager
Quality Assurance Manager
Recordati
Lyon, France
Job Purpose
The QA Manager is responsible:
- for the management of the QA activities related to manufacturing operations, as well as the QA support of the industrial technology transfer of the product when applicable;
- for product quality processes according to quality standards and will ensure that all administration relating to these tasks is maintained and updated as required.
Key Responsibilities
The QA Manager manages and/or takes part of:
- the quality processes related to the products distributed by the company: trend analysis, writing of Annual Product Quality Reviews, Monitoring of the stability analysis and Investigation of complaints and deviations related to the products, management of change control and review of batch files;
- the direct report(s) to ensure that the tasks/activities she is responsible for are carried out on time and in full;
- the objective is to ensure compliance of these activities with Good Manufacturing Practices, as well as with applicable national and international regulatory directives.
Required Education
- PhD in Pharmacy, entered in section B.
Required Skills and Experience
- Minimum 6 years of professional experience in the pharmaceutical industry, ideally in production;
- Clear understanding of the environment, regulations and constraints of the pharmaceutical industry.
Technical Competencies
- PhD in Pharmacy, entered in section B;
- Fluent in English. Second European language an advantage but not essential.
Required Behaviours and Competencies
- Demonstrate leadership in working with subordinates, peers and superiors in a multicultural environment;
- Autonomy in daily activities.
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