Microbiology Laboratory Manager
Hochster pharmaceutical industry
Total years of experience :14 years, 3 Months
Managing and overseeing laboratory work.
Supervise the performance of the environmental monitoring programs nonsterile area, and laboratory sterility testing. Record, evaluate and trend the environmental& water 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 microbiological laboratory.
Training the new microbiological analyst in the microbiological laboratory and co-ordinate with the Quality Control manager the Technology transfer for both the new analyst and the new test procedure.
Prepare the SOP’s necessary for the microbiological laboratory activity.
Selection of new staff and partner in the assessment cycle.
Continuous coaching and problem-solving skills to improve performance.
Develop plans for team motivation and recognizing successes
Establish teamwork and align efforts and data between the team and sharing data and knowledge.
Ensure and maintain good communication behavior and healthy environment among colleagues.
Conduct assigned testing independently within constraints of lab scheduling.
Perform testing in accordance with SOPs and regulations (ISO, GLP).
Maintain complete and comprehensive records for study integrity.
Make detailed observations, documents results and performs data analysis(Trend analysis)
Demonstrate a consistently high level of quality of work.
Operate and maintain lab equipment as required by SOPs and testing procedures.
Utilize problem solving/trouble shooting skills.
Communicate deviations, progress and interim results to the Management team.
Investigate anomaly/excursions related to microbiological test results.
Monitor, adjust, create and validate test methods to ensure they are current and compliant with industry standards and regulations.
Create/revise SOPs, laboratory records and other related documentation as assigned.
Train and develop technicians in microbiological techniques.
Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment.
Managing and overseeing laboratory work.
performing all the microbiological test and Activities and Assays for non sterile pharmaceutical Dosage forms:
1-Microbial limit test
2-Microbial Assay of Antibiotics
3-microbiological Analysis of Water
4-Media preparation and sterilization
5-Growth promotion test
6-Preservative efficacy test
7-Microbial Identification Techniques
8-Environmental monitoring for non sterile manufacturing Facilities
9-Microbiology Documentation practices
10-cGMP for pharmaceutical Industries
11-Analytical method validation
-Daily complete run for the final products according to Egyptian organization for standardization and quality control.
-Knows microbiological techniques, methods of analysis terminology, equipment and supplies.
-Performs Biochemical tests as ( confirmatory tests).
-Performs sampling and microbiological examination of raw materials and packaging materials.
-Microbiological tests of water.
-Microbiological Swaps for machines and workers.
-follow up the Manufacturing process : Handling, Processing and storing to detect the mistakes that cause microbiological contamination.
-Daily reports for tested samples.
-Participates in quality improvement process.
Master research title: Microbiological and biochemical studies on some microbial active secondary metabolites produced by certain extreme microorganisms. Published paper in inventi speaking knowledge: Antimicrobial Activity of Isolated Actinomycetes and Optimization of Bioactive Metabolites Production
