Job Title Microbiology Section Head
Vacancy Deadline(mm/dd/yy) 11/30/2017
Languages Arabic
English
Languages English, Very Good
Country Egypt
City Qalyubia
Job Category Pharmacy
Job Type Full Time
Job Level Senior
Description o Plan and organize work load in microbiology lab according to the production needs.
o Monitor laboratory inventory and issue laboratory needs through purchasing and follow them till completeness.
o Maintenance of standard strains.
o Organize and keep reference microorganisms.
o Sterility test of sterile products
o Microbial limit test for raw materials & finished products.
o Bacterial endotoxin test (LAL test) for pyrogen free materials & products.
o Water analysis (Total viable count and tests for specified microorganisms)
o Check and review the analyst note book, analysis data and certificate of analysis.
o Maintain a solid controlled documentation system in QC department.
o Technical review and approval of SOPs of the laboratory.
o Check and follow cGMP and GLP compliance in the lab.
o Prepare and validate test methods for products Microbial Limit Tests and Sterility tests and LAL tests.
o Validation of the shelf life of disinfectants used in sterile areas.
o Validate media preparation hold time.
o Media preparation and handling including growth promotion test.
o Monitor the strict implementation of the environmental monitoring program: (Sterile and Non-sterile)
o Active air sampling.
o Exposure plates.
o Surface sampling by RODAC plates or transport swabs.
o Personnel monitoring (finger prints and gowning swabs)
o Particulate air monitoring (non-viable)
o Monitor the maintenance program of microbiology laboratory premises and equipments
Check and follow the calibration program of the QC laboratory equipments
o Biological validation of autoclaves, ovens and tunnels by biological indicators
o Gram Staining & Microbial identification to genus and species level
o Trend analysis
o Environmental isolates
o Identification of isolates to genus and species level
Qualifications B.S. in Pharmaceutical Sciences Experience: Minimum of 5 Years relevant experience in Microbiology activities in sterile area. Experienced in preparation and validation of test methods for sterility test, Microbial limit tests and LAL test. Experienced in performing disinfection efficacy and validation study and identification of environmental isolates. Previously performed media preparation hold time study. Skills: - Strong technical writing and documentation review skills. - Good coaching skills to help others improve and develop technical skills. - Attention to detail and high level of accuracy - Perform with frequent interruptions and/or distractions. - Highly self-motivated, well organized, and able to develop alternative solutions to issues. - Excellent Communication Skills - Ability to analyze Information, technical Understanding, promote process improvement and report research results.
Gender Any
Car owner Any
Education major Pharmacy
Experience 4 - 5 Years.
Compensations Upon company policy. Insurance ( Social , Medical) Transportation. Profit share.
Salary (L.E.) Negotiable
Job Contact Email hr@marcyrl.com
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