وصف الوظيفة
Job Summary:
To perform pharmaceutical microbiological procedures in compliance with USP, WHO regulations and other regulatory/audit groups to ensure the accuracy of test results and raw data generated.
Job description:
- Perform Environmental monitoring sampling and sample preparation
- Reading & recording Results of EM sample
- Start Lab investigation for OOS and OOT Results
- Arrange Media stock to be prepared according to production plan.
- Water analysis
- Bioburden test
- Identification of Microorganism using gram stain & advanced identification system
- Raw material sampling
- Growth promotion Test
- Perform Microbial limit test for Raw & Finished product
- Perform Bacterial Endotoxin test for Raw material & Finished product
- Label claim assay for any lysate new Lot
- Handling biological Indicator
- Media Fill inspection
- Disinfectant Efficacy test
- Monitor compressed air
- Sanitize Sterility room
- Perform Sterility Test
- Perform Gown Qualification trials
- Executes validation studies, prepares summary reports, and changes controls in order to keep management informed.
- Prepares laboratory records while maintaining accuracy, completeness, compliance and conformance to specifications in order to be ready for both internal and external audits.
Qualifications, Experience, & Skills:
Minimum Qualifications:
Bachelor’s degree in Science or Pharmacy
Minimum Experience:
1-3 years experience in the same field