Leading Microbiological Analytical and Environmental Monitoring of Oncology sterile injection facility.

Specialist in Microbial Antibiotic assay and Vitamin B12 assay (Method development,Method validation & Verification),Disinfectant Efficacy test (DET) as per USP <1072>,Diluent compatibility test (Ingress study) support given to pharmaceutical for regulatory submission.

Lead the testing section for the activity of Microbial Antibiotic assay (Three level method and Five level method),Vitamin B12 microbial assay,Microbial enumeration test,diluent compatibility test,Antimicrobial effectiveness testing,sterility testing,bacterial endotoxin test by gel clot technique.Monitoring and verification of newly installed Equipment qualification (URS, DQ, IQ,OQ & PQ) as well as re-qualification of microbiological instrument/equipmentReview and performing Calibration of equipment and Preventive maintenance of Instrument in microbiology laboratory.Handle compliance and QMS of microbiology department during audit observation.Media fill Validation, Cleaning validation, hold time study of product and analysis completed and submits data within time.Working in Contract research organization (CRO) to follow the timeline of pharmaceutical client and release the report for regulatory batch release.

Implemented systems that improved organizational workflow efficiency by 20% for cost saving.Directed employee training initiatives across various departments in order to maximize productivity and compliance activity.Lead the protocol preparation for method, development, Method validation,Method verification of microbial testing.Method validation of Bacterial endotoxin test of water for Injection, Raw material and finished product by gel clot method.Method development, Method Validation & Method Verification for Microbial Examination of non-sterile product –By pouring Method and Filtration method

Prepared presentations for senior management on current operations status as well as future plans.Developed and implemented new strategies to improve operational efficiency and reduce costs in microbiology laboratory.Equipment qualification (URS, DQ, IQ,OQ & PQ) ,Calibration of equipment and Preventive maintenance of Instrument in microbiology laboratory.Faced the USFDA(c-GMP) product specific and facility audit also USFDA (Virtual audit)Following the Data Integrity of online reporting Following ALCOA++ system.I have ability to team building, leadership skills and handling project of microbiology.

Method validation of Bacterial endotoxin test of water for Injection, Raw material and finished product by gel clot method.Method development, Method validation & method verification test of Bioassay of antibiotic molecules as per USP <81>.Qualification of Working standard of bioassay as per USP, BP and Ph.Eur guidelines.Bioassay analysis of Antibacterial, Antifungal and Vitamin B12 by three level and Five level method of finished product.Method development, Method Validation & Method Verification for Microbial Examination of non-sterile product –By pouring Method and Filtration method.Method Validation of sterility testing by open method and closed method.Method validation and Method Verification of Antimicrobial Efficacy Testing.Media fill Validation, Cleaning validation, hold time study of product and analysis completed and submits data within time.PRACTICAL ASEPTIC DEMO-Giving practical Demo of sterility and Microbial examination of non-sterile products in presence of MHRA and C-GMP USFDA Auditor.AUDIT FACED● USFDA(c-GMP,PSA)● USFDA (Virtual audit)● MHRA● WHO

Performed microbial testing of raw materials and finished products, recording and approving information for database.Developed protocols and procedures for validating new culture media formulations and testing their performance in bacterial growth experiments.Conducted research on the effects of various environmental factors on microbial growth, utilizing aseptic techniques, sterile equipment, and other microbiological tools.Environment monitoring by settle plate, Air sampling (21 CFR software), contact plate, drain monitoring and personal monitoring.Education