Director/Associate Director (Micro/EM)

Responsibilities
1. Manage all operational aspects of the Quality Control Microbiology and Environment Monitoring functions in support of raw material, in-process, drug substance and drug product lot release, stability testing, and environmental monitoring (EM) for site's projects. 2. Oversee microbiology related testing and method qualification, including bioburden, CCIT, endotoxin and sterility testing of raw material, in-process and final products. Perform technical review of USP/EP/JP/CHP to ensure methodology and procedures are compliant with the current standards. Ensure in-house operations are complying towards latest GMP and regulatory authorities requirements. 3. Oversee the set-up of environmental monitoring strategy, conduct routine monitoring and perform trend analysis, Isolates identification. Perform or participate in quality risk assessment when necessary. 4. Oversee the investigation of microbiological quality problems in release and stability testing, utilities and ...