
Sterility Control Manager
3 days ago
We are seeking a highly experienced Sterility Control Manager to join our team at Sehat Medical Devices Pvt. Ltd.
The successful candidate will be responsible for overseeing microbiological testing and developing protocols to ensure the sterility of our products. They will work closely with cross-functional teams to optimize testing protocols, identify process bottlenecks, and minimize product defects or rework.
The ideal candidate will have a strong background in microbiological methods and in-process product testing in the medical device or pharmaceutical industry.
Main Responsibilities:
- Oversee routine and specialized microbiological testing (e.g., sterility, bioburden, environmental monitoring) to ensure compliance with global standards (ISO 11737, ISO 10993, USP Class VI).
- Develop, implement, and maintain SOPs for microbiological protocols, ensuring all documentation is accurate and up-to-date.
- Collaborate with Production, Engineering, and R&D teams to optimize testing protocols, identify process bottlenecks, and minimize product defects or rework.
Key Qualifications:
- Bachelor's or master's degree in Pharmacy, Microbiology, Biotechnology, Biomedical Engineering, or related fields.
- Minimum 5 years of experience in quality control or quality assurance, with a strong background in microbiological methods and in-process product testing in the medical device or pharmaceutical industry.
- Proven track record of managing a QC team and handling quality-related projects end-to-end.
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