Sreedevi J
About Candidate
• Master Degree In Microbiology and having One year Experience in testing of sterile drug product and aseptic filling process of sterile Pharmaceutical / Biopharmaceutical products.
• Responsible for technical and quality oversight for activities within the QC Microbiology department. The Specialist in technical support with regard to method verification, Environmental Monitoring, Utilities and all other lab-based activities.
• Good knowledge of current regulatory requirements for QC / Sterility Assurance in support of GMP operations supporting clinical and commercial manufacturing.
• Ability to work Independently & Collaboratively in a Multidisciplinary team Environments while providing operational support Capability
• Built a strong culture of compliance with Adherence to Quality system requirements in addition to corporate policies and Training requirements
Location
Education
Master of Science in Microbiology First class with Distinction Secured University Fifth Rank
Bachelor of Science in Microbiology First Class
Work & Experience
• Responsible for technical and quality oversight for activities within the QC Microbiology department • Carry out routine sample analysis and Microbiology Laboratory Maintenance • To perform MLT testing and method validation as per approved procedure and method • Perform environmental monitoring of production Microbiology and R&D area and reporting • Perform GPT, Inoculum preparation and maintain the pure cultures • Receipt and allotment of AR number in the respective sample entry registers • Ensuring that the analysis are conducted using calibrated instruments and approved standard materials • Perform water validation Phase I, Phase II and Phase III • Perform chlorine validation, cleaned equipment validation and disinfectant validation • Perform Environmental Surface Monitoring and Personal Monitoring of production area and reporting • Perform Environmental Drain Point Monitoring of production and Microbiology area and reporting • Perform Compressed Air Monitoring and reporting • Perform Environmental Monitoring validation