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QA expert- QP (m/f/d)



Quality Assurance
Posted on Saturday, October 28, 2023

About the Role

Location: Mengeš #LI-Hybrid

We bring life-saving medicines to millions of people. We are at the crossroads of the latest advances in medical science and innovative digital technology. Everything we do is in line with our commitment to quality and to providing safe active substances for patients. Our commitment to quality is based on science, we innovate and our work is patient-centred. Whether you are involved in development, production, maintenance, compliance or analysis, your contribution will have a direct impact on patients. " Without quality checks and quality assurance at all points in the process, we cannot reliably build patient trust. Do you value this mission?

As the QA expert- QP, you will be responsible for carrying out quality control of the medicines produced. Your role will be to release medicines for the purpose of uninterrupted customer service and ensure the development of an internal quality system in accordance with legislation, internal regulations, good practices and business objectives.

Key Responsibilities:
• Release of biological drug substances from own production for further production of final biopharmaceutical products and/or release of drugs to the market in accordance with directives and local legislation, provisions of contracts with partners and internal procedures.
• Responsibility for review and assessment of production and analytical documentation.
• Responsibility for evaluating batch adequacy and marketing authorization compliance.
• Ensuring the development of an internal quality system with good pharmaceutical practices, legislation and Novartis standards.
• Involvement in deviation and change management process.
• Involvement in transfers and new product launches.
• Management of preparations and participation in inspections.