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Job Description
The position holder is responsible for the microbiology laboratory and the analysis of the in-process validation. He/she is also responsible for lab investigations when needed.
- Coordinate the Microbiological laboratory activities.
- Facilitate all the equipment, reagents, media, and instrument necessary for performing the microbiological analysis and tests.
- Participate in the Process validation regarding the microbiological analysis
- Prepare and Follow the performance of the environmental monitoring programs of the aseptic processing area, Non-sterile area, and laboratory sterility testing. Record, evaluate and trend the environmental monitoring data.
- Perform the microbiological laboratory investigation in case of out of specification results have occurred with microbiological laboratory analyst.
- Control the GMP documents regarding the microbiological laboratory.
- Fulfill other related tasks as asked by management and as arising from the business.
- A sampling of water samples (in water station) and bulk samples
- Identification of bacterial strains deducted in samples analysis
- Sterilization testing of finished products
- Microbial limit test of not sterilized products and R.M
- LAL test both quantitative and qualitative
- Water analysis and bio-burden test
- Sampling and, Monitoring Environmental
- Identification of microorganisms
- Bioburden test and Preparation of tools
- Sterilization assurance (Heat/cool)
- Documentation and trend analysis
- LAL test (get clot and quantitative)
- Water station analysis
- Deviation and Q.C fails completed by data
- Sterility test, Media preparation
- Develop SOPs as needed.
- Preparation, Handling and keeping of microbiology suspension.
Job Requirements
- Bachelor’s degree in Pharmacy or scientific
- 2 to 3 years of experience.
- Good command of English language and computer skills
- High communication skills and able to work in a team and able to interact with various priorities.
- Active, organized and planner with high attention for details.
- High observation skills.
