Yogita Phalke

• Working as section head -Supervising, monitoring, designing protocol & assigning work to the team
• QMS Implementation
• Reviewing daily records & all the related documents
• Monitoring revival, maintenance & calibration of standard microbial Cultures received form WDCM, ATCC, NCTC & all other standard microorganisms (CRM)
• Monitoring daily quantitative & qualitative analysis of dehydrated culture media, ready prepared media & raw material w.r.t microbiological quality control testing
• Responsible for NABL accreditation work for the laboratory: Preparing quality manual, filling all the necessary data into the web portal, conducting Internal audits, MRM, conducting Proficiency testing- planning, execution till results submission; communicating with CAB coordinator, Authorized signatory & Contact Person for the CAB, Managing a team of 27 people
• Proficiency Testing/ External Quality Assessment/ Inter-laboratory comparison testing/ Inter-Laboratory testing: Identification of suitable laboratory for the participation, planning of the testing of the sample, Execution, reviewing & reporting the test results
• Internal, External & Certification audit preparation as per the agenda – by TUV, Quality Austria Central Asia
• Conducting audit as per ISO 17025:2017, ISO 9001:2015, ISO 13485:2016 – Internal as well as external (vendor audits)
• Addressing Internal and External Quality Issues, CAPA report & compliance report preparation, Audit management, Inspection, Change control, Deviation, Risk Assessment
• Preparation of SOPs, work instructions & procedures, using DMS software (Document Management System)
• Supporting the technical, operational, and commercial leadership of the team
• Verifying Microbiological Testing Record & physiochemical record of RO water, Purified Water (Milli Q water), & grade water
• Reviewing Environmental Monitoring data of laboratory area by settle plate method, air sampling method, of Dynamic Pass box
• Handling queries & complaints of the customers
• Case Studies & rectification
• Service provision for Identification of unknown & environmental isolates using MALDI-TOF MS Microbial Identification system from AutoBio & Bruker
• Authorized signatory for test reports as per ISO 17025:2017
• Vendor Questionnaires for Identification service provision
• Process validation
• Reviewing Equipment Qualification protocol- Calibration of MME
• Delivering Training on ISO 17025:2017 clauses, on new SOPs & for handling and preservation of microbial cultures
• Technical advisor for cross-departmental functioning & internal /external customer queries
• Reporting to the Sr. Quality Assurance manager, Quality Control Manager, Sr. VP, Director & Managing Directors of the company
• SAP transactions for preparation of Technical Specification of new products.

• Worked as a Section head for Microbial Culture Maintenance Section
• To implement and maintain quality control system and GLP in the department
• Monitored work activities and prepared data and documents of progress reports to ensure proper GDP
• Responsible for microbial cultures required for testing of Finished product of Dehydrated Culture Media, Raw Materials, Ready Prepared Media Materials & Plates
• Maintained quality control objectives and coordinated with managers
• Preparation of Documents, SOPs, Work Instructions, Protocols, etc as per the Standards
• Facing - Internal audits, Customer audit & Certification audits
• Analyzing work problems related to microbial cultures and evaluated resolutions to prevent delays in the production area
• Proposed quality procedures and informed managers of current status and updates in line with daily quality control tests
• Assisted in organizing training activities to new employees in relating to quality control techniques
• Coordinated with the employees for the daily work and any new projects
• EHS-SAP work entering data through SAP for Technical Details, MSDS, and Labels required for multilingual form

• Calibration & Maintenance of microbial cultures required daily
• Preparation of Working Stock cultures from Reference Stock cultures
• Aseptic Inoculation of all the cultures from Master Cultures and Cryovials
• Daily provision of fresh cultures for all sections as required for Growth Promotion Test & other quality control test work
• Presumptive Identification of Environmental Monitoring Isolates, their maintenance & Disinfectant efficacy
• Preparation of Technical Details of Ready Prepared Media through SAP transection

• Performed Antioxidant assays using Goat liver extracts
• Performed Antibacterial activity, Extraction for medicinal plants
• DNA Isolation
• PCR, Gel Electrophoresis
• Maintained standard Microbial Cultures
• Helped in documentation

• Supervising, monitoring, designing protocol & assigning work to the team
• Regular checks on completion of all the related documents & records
• Monitoring revival, maintenance & calibration of standard microbial Cultures received form WDCM, ATCC, NCTC & all other standard microorganisms (CRM)
• Monitoring daily quantitative & qualitative analysis of dehydrated culture media, ready prepared media & raw material w.r.t microbiological quality control testing
• Internal, External & Certification audit preparation as per the agenda
• Addressing Internal and External Quality Issues, CAPA report & compliance report preparation, Audit management, Inspection
• Preparation of SOPs, work instructions & protocols for equipment, projects & QA/ QC work
• Handling queries & complaints of the customers
• Case Studies & rectification
• Waste water treatment project by using Mutag BipChips (Germany)
• Identification of unknown & environmental isolates using MALDI-TOF Biotyper system- Bruker
• Equipment Qualification protocol- Calibration of MME
• Training new microbiologists in regards to handling and storage of cultures
• Reporting to the Quality Control manager & Managing Directors
• SAP transactions

Additional responsibilities :Working as a Deputy Quality Manager– as per ISO 17025: 2005 requirements

July 2017 –2020 (as per NABL) HiMedia Labs. Pvt. Ltd., Mumbai -400086.

• Conducted Internal audits as per ISO 17025
• Regularly checking the NABL website for the document updates & webinars if any.
• Web Portal entries for Assessment audit
• Prepared Quality Document (Quality Manual)
• Providing technical as well as quality testing assistance for ISO 17025 accreditation by assessing, auditing, preparing and reviewing documents, and providing necessary training for onsite staff.
• Performing Proficiency Testing (PT) & Inter-laboratory comparison (ILC) testing- External Quality Assessment for food & water sample (Public Health England, London)
• Analytical Method Validation- Growth Promotion Test
• Exposure to the concept of "Measurement of Uncertainty"
• Participating in all Quality Management System activities, focusing on investigations, CAPA and Internal auditing in order to evaluate and trend the laboratory's progress towards ISO 17025 accreditation and its maintenance.