Job Overview
The Sterility Assurance Lead is a pivotal role in ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies.
This role extends beyond microbiological testing to encompass comprehensive oversight of aseptic manufacturing, contamination risk management, and adherence to global regulatory requirements.
The successful candidate will drive sterility assurance initiatives while fostering a culture of quality excellence.
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* A Bachelor's degree in Microbiology, Biotechnology, or a related discipline.
* 2–4 years of sterility assurance or aseptic manufacturing experience.
* Strong understanding of Annex I, US, and EMA GMP regulations.
* Practical experience in regulatory audits.
* Proven experience in contamination control strategies, including cleaning and disinfection validation.