HIMANSHU SHARMA

• Inspection and approval of incoming raw materials.

• Approval and reconciliation of labels.

• Perform microbiological testing of in-process and finished products.

• Conduct tests for bioburden, stability and validation samples.

• Cleaning and sanitization of work areas.

• Create, revise, review and/or approve control documents including standard operating procedures, manufacturing instructions, book of methods, material specifications, and reagent formulations.

• Participate in Raw Material Qualification, Stability Validation and Equipment Validation

• Participate in nonconformance investigations.

• Investigate customer complaints and inquiries.

• Daily monitoring of temperature of refrigerators, incubators and equipment.

• Documentation review including batch records, equipment maintenance and calibration records, cleaning and sanitization checks and etc.

• Established effective employee schedules and delegated tasks to take advantage of individual abilities and meet expected demands.
• Evaluated employee skills and knowledge regularly, training and mentoring individuals with lagging skills.
• Delivered superior training and leadership to teams to boost performance and help team members achieve performance targets.
• Prepared shift summary reports for supervisor and communicated regularly on goals and progress.
• Built performance-oriented culture with satisfied, hardworking employees by clearly highlighting employee success and developing leaders from within.
• Resolved customer complaints and issues and offered thoughtful solutions to maintain customer satisfaction.
• Provided ongoing support to employees during challenging situations, offering guidance on problem-solving techniques for improved efficiency outcomes.

• Served as subject matter expert (SME) on environmental regulations and policies.
• Performed Microbiological Analysis of Water
• Routine environmental monitoring of air, surface, water, and gas
• Completed complex technical field environmental surveys for development of Vaccines
• Obtained and maintained permits and plans.
• Analyzed scientific data and performed Environmental checks.
• Prepared, reviewed and updated environmental investigation reports for organization.
• Provided system and component design reducing negative impact on area environment.
• Advised corporations and government agencies of procedures to follow in cleaning up contaminated sites to protect people and environment.

• Performed water analysis
• Promote environmental awareness and engagement
• High Performance Liquid Chromatography (HPLC), UV-spectrophotometer, hydrometer, viscometer, pH meter
• Skilled in the use of aseptic technique, pipette handling, dilution procedures
• Microbial enumeration including standard plate counts, Membrane Filtration Technique (MF), Most Probable Number (MPN)