12 Oct
Pathogenia Lab
Davanagere
Role Description
We are seeking a Microbiological Subject Matter Expert for a consulting role with extensive experience in FDA regulated Pharmaceutical Laboratories. The ideal candidate will provide expert guidance on microbiological testing, contamination control, and regulatory compliance in alignment with industry standards such as USP, EP, and GMP. This role will involve providing specialized consultation, supporting laboratory operations, optimizing microbiological testing processes, and ensuring compliance with industry standards such as cGMP , ICH , and FDA guidelines.
Qualifications
Education: Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, or a related field. A Ph.D. in Microbiology is a plus.
Experience:
- 10+ years of experience in microbiology within pharmaceutical laboratories .
- In-depth knowledge of microbiological testing , sterility testing , and endotoxin testing .
- Extensive experience with regulatory guidelines and quality systems (cGMP, ICH, FDA, ISO 17025 ).
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