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QA expert for the production process of biological agents (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 for the production process of biological agents, you and your colleagues ensure that GMP compliance requirements are met. Your role includes initiating, coordinating and carrying out all necessary activities to achieve compliance. As an expert, you also have an advisory role on GMP matters for all employees in the value chain.

Key Responsibilities:
• Ensuring introduction of new products into production, implementation of new equipment, improvements and increases in the capacities of production processes.
• Participation in the transfer of production processes from development or other production locations.
• Participation in ensuring regular production processes.
• Participation in finding solutions and improvements and introducing changes with colleagues from production, MS&T (manufacturing science and technology) and other functions.
• Ensuring that all activities comply with current good practices (cGxP) and data integrity.
• Approving the validation/qualification of processes, equipment and systems and input materials.
• Management of preparations and participation in audits and inspections.