Nagmani

More than 19 Years of experience as Medical Laboratory Operation Certified CAP Auditor for International Audits in CAP accredited organization Certified Internal Auditor for ISO 15189: 2022(NABL) Having complete experience of one new Laboratory setup and Validation of different.

• Develop, implement, & maintain the Quality Management System (QMS) in alignment with NABL, CAP, ISO15189 & other applicable standards.
• Oversee & manage the day-to-day activities of the assigned laboratory area, ensuring operations run smoothly & safely.
• Lead internal & external audits & ensure timely closure of non-conformities.
• Monitor lab equipment, tools & supplies, ensuring proper maintenance, calibration & availability to support ongoing research & testing needs.
• Implement & enforce strict laboratory procedures, including proper handling of chemicals, biological materials & hazardous substances.
• Manage end-to-end operations of the National Reference Lab, including samples workflow, resource planning, turnaround time (TAT), Kit utilization & Recipe cost optimization.
• Drive continuous improvement initiatives in quality, safety & process optimization.
• Collaborate with senior leadership to define & execute strategic goals.
• Provide guidance on technical processes & troubleshooting & assist in resolving complex issues that arise within the lab environment.
• Oversee scheduling, performance reviews, training & development of lab staff, fostering a culture of continuous learning.
• Manage lab staffing levels to ensure adequate coverage for experiments, testing or shifts.
• Review of quality & system related documentation & records of their respective department/labs as per defined period.
• Serve as the key liaison with accreditation bodies, vendors & external consultants.
• The duty roster of staff is made to cover 24 hours working of lab round the year.
• Conduct regular reviews, performance assessments, & training programs for staff.
• Ensuring that all personnel at the facility will work in accordance to established SOPs. Decides priorities in testing. Prepares competency testing.
• Implements cross training. Oversight and coordination of all day to day activities at the testing facility and ensuring the goals set are accomplished in a timely manner, which includes controlling inventory, troubleshooting instrument and method problems.
• Ensuring facility compliance with ICMR/NABL/NABL/CAP guidelines including data upload and storage of samples.
• Maintains quality results by consulting with pathologists.
• Developing and performing parallel and validation testing and new lab setup.
• Maintains medical laboratory supplies inventory by checking stock to determine inventory level, anticipating needed supplies, placing and expediting orders for supplies, verifying receipt of supplies.
• Developing a strategy to develop the Clinical Diagnostic & Clinical Trial Business.
• Maintaining Operations efficiency, quality and TAT and make good use of IT & LIMS.
• Monthly MRM to improvements of quality and productivity of report and manpower.
• Maintains medical laboratory staff by recruiting, selecting, orienting, and training employees.
• Maintains medical laboratory productivity by monitoring workload of functional areas.
• Under supervision Infectious samples send out of different purpose to different organization like IGIB for Genome Sequencing, ILC for AIIMS and NCDC (Specially COVID samples). Ensuring facility compliance with ICMR/NABL/NCDC guidelines including data upload and storage of infectious samples. Coordination with ICMR, NABL and Local Government Regulatory Bodies on relevant issues regarding infectious disease testing & supporting audits etc.
• Biochemistry instrument like: Shimadzu High Performance Liquid Chromatography (HPLC for Vit-A & E).
• Immunology instrument like: ELISA Reader & Washer (BIO-RAD).
• Assist principal Investigator/Manager during audit process (CAP Audit, NABL Audit, QA audit, any regulatory/Sponsor audit (Like Clinical Trial etc) at all times.
• Responsible for preparation for relevant standard operating procedures as per the NCCLS/CLSI & EUCAST guidance and other regulatory requirements.
• Reviews survey (CAP/ILC/EQAS) entries and results.
• Analyze clinical samples for presence of antigen specific antibodies. Interact with CROs performing serological assays for BE's vaccine trials other CT projects. Prepare SOPs and report for method transfer. Supervise junior colleagues and assess the quality of their work.

• Manipal Academy of Higher Education, Bachelor’s Degree in MLT
• Vinayaka Mission University, Master Degree in Biotechnology

• Training Programme on Medical Laboratories-Quality Management System & Internal Audit as per IS/ISO 15189:2022
• Certified for Educational activity titled Inspection Team Member Training CAP (College of American Pathologists)
• ICMR-WHO-IUMS-PGI 10th National Training Course (Diagnostics Mycology- Conventional & Molecular Techniques, PGI Chandigarh)
• WHONET Training Workshop for WINSAR-D 2019
• Successfully attending the webinar on “Role of Sequencing in SARS-CoV-2 discovery, diagnostics & disease surveillance” conducted by FIND

• Dr.Malvika Srivastava, Dr.Anurag Bansal, Mr.Nagmani, Mr. Iqbal Ahmad, Mr. R. Venkateshwar, Vancomycin MIC creep in clinical isolates of Methicillin resistant Staphylococcus aureus in Indian sub-continent, Archives of Pathology and Laboratory Medicine, 09/01/18
• Dr Suryasnata Das, Dr SL Jain, Dr Anurag Bansal, Mr. Nagmani, Ms. Jyotishree, Mrs. Sakshi Mattoo, Ms. Razia Shafi, Mr. Santosh Kumar Gupta, Comparison of LineProbe Assay(LPA) & Phenotypic testing for Detection of Resistance to First-Line Antitubercular Drugs in Mycobacterium tuberculosis complex Isolates.