Regulatory affairs specialist Jobs in Wörthsee
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Regulatory affairs specialist • worthsee
Development Expert Sterile Liquids (f / m / d)
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Chromsystems GmbHGermeringDevelopment Expert Sterile Liquids (f / m / d)
Aenova Holding GmbHStarnberg, Germanyfor the site Starnberg (Percha), Germany
Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Our site in Starnberg is the headquarters of the Aenova Group.
Your key responsibilities
- Lead, oversee and advise in sterile liquid development and MS&T projects across the Aenova Group
- Lead the development and optimization of aseptic formulation and process development for sterile liquid pharmaceuticals, ensuring compliance with project objectives and regulatory requirements
- Implement global standards and best practice for product development, optimization and manufacturing of sterile liquids
- Implement QbD principles to establish robust, scalable, and reproducible manufacturing processes for sterile liquid drug products
- Stay up to date on industry regulations and guidelines related to sterile pharmaceutical development and ensure adherence to quality standards and regulatory requirements
- Scout technological advancements in sterile liquids and implement new technologies to enable innovation
- Work closely with internal and external stakeholders in e.g. analytical development, regulatory affairs, and quality assurance to ensure alignment and compliance throughout the development process
Your profile
Your motivation
Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation!If you have any questions, I - Sophie Scholl / Human Resources - will be happy to help you :