Aseptic Quality Manager (España)

Aseptic Quality Manager (España)

14 sep
|
Ethypharm
|
España

14 sep

Ethypharm

España

Ethypharm is a leading mid-sized integral pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive impact on society and the environment.
Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms.
With a global presence in 68 countries, the company markets its products directly in Europe and China, and has strategic partnerships in the EMEA, NA, LATAM and APAC markets.
Ethypharm works closely with the authorities and healthcare professionals to ensure that its medicines are used appropriately and that patients have access to them.
To find out more about Ethypharm, visit and follow us on LinkedIn.
Aseptic Quality Manager
- Accountable for sterility assurance across site




- Contamination control strategy (leadership of the strategy: periodic review and update)
- Definition and implementation of environmental monitoring program. Management of trends and improvement of processes based on their results
- Parthership with QC micro lab to develop strategies of monitoring and bioburden control
- Media Fill Program (management of strategy, definition of runs, oversee of execution)
- Aseptic behaviour definition, development of training program and oversight (management). Definition of gowning strategy and cleaning processes
- Sterilization processes (suport to other departments to define sterilization strategy and oversight of execution)
- Risk assessments and improvement programs (implement/manage - against current and future expectations)
- Environmental monitoring investigations (i.e. Adverse EM trends, media fill failures)
- Review & approve any Major/Critical deviations and change proposals with Ster

📌 Aseptic Quality Manager (España)
🏢 Ethypharm
📍 España

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