Qualifications of equipment's. * Analyst qualifications. * On the Job training. * Testing method validation. MAJOR AUDITS FACED: USFDA, TGA, MHRA, ANVISA (Brazil), UKRAINE, GSK, NHL, W.H.O, DRUG CONTROLLER AUDIT. VALIDATION EXPOSURE: * Media fill validation * Antibiotic bio assay * Excel sheet validation for calculations. * Sterility method validation * Bioburden method validation * Microbial Enumeration Test * Bacterial Endotoxin test method validation. * Autoclave validation * Disinfectant validation * Environmental monitoring performance qualification * Water System Validation * Personnel Qualification * Analyst Qualification * Media shelf life validation * UV performance verification * Plate Exposure validation * Glassware hold time validation * Exposure study validation * Effect of vacuum on microbial growth * Hold time verification of rehydration culture contents (Bio balls) PREVIOUS TECHNICAL PROFICIENCY: * Sterility Testing by Membrane filtration and by direct inoculation method. * Maintenance of culture of Microorganisms and Growth promotion test for media. * Water testing by Pour plate and Membrane Filtration Method. * Microbial Enumeration Test * Bacterial Endotoxin test * Analysis of drain points * Environmental Monitoring * Preservative Efficacy Test * Identification of in house Isolates. * Handling of Biological indicators. * Preparation of annual trends for Environmental monitoring, Water, Compressed air and drain point QUALITY ASSURANCE SKILLS ACQUAINTED WITH: * Preparation of validation protocol * Handling of Out of Specifications * Handling of change control * Training to the other team members in regard of microbiological aspects.

Highlights:

• Microbiology
• Quality
• Quality Assurance
• Quality Control
• Distribution
• Test
• Training
• Audit
• Communication Skills
• English Language