Quality Control Specialist
Position: Quality Control Specialist
- Location: Tuas, Singapore
_**About the job:
**_
_Our Company_
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s life. We turn the impossible in to the possible by discovering, developing and delivering medicines and vaccines for millions of people around the world.
The Sanofi Modulus is at the cornerstone of our strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address biologics business challenges.
In this context, we are looking for one Quality Control Specialist to manage the Environmental Monitoring (EM) Program on site and contribute to related laboratory testing and support activities. This role ensures that manufacturing areas, cleanrooms and critical utilities are monitored, trended and controlled in line with cGMP, regulatory expectations and Sanofi quality standards.
Key Accountabilities
1\. Environmental Monitoring Operations
- Perform routine Environmental Monitoring (EM) activities, data review, trending, and documentation in accordance with GMP requirements.
- Develop EM sampling plans for routine monitoring, BSC EM sampling, isolator EM sampling, aseptic qualification, and equipment qualification activities.
- Coordinate and manage the EM sampling schedule to ensure all routine and ad hoc activities are completed on time.
- Review EM sampling results in LIMS to ensure data accuracy, completeness, and compliance...
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