Nikil N

Thorough Quality Assurance Manager creates successful quality assurance strategies and processes. Accomplished at identifying deficiencies and initiating solutions to problems. Experienced performing both process and outbound inspections.

• HPLC VWD
• Agilent1260 infinity with VWd.
• SHIMADZU LC 2010 cHT with VWD.
• Waters e2695 with Qda, PDA, VWD
• HPLC-UV/FLD
• Agilent 1260 infinity with FLD and Kobra cell For post column Derivatization
• HPLC - pda and Qda (single mass)
• UPLC with DAD and RID
• Agilent 1290 infinity 2 with DAD and RID For Amino acids and Sugar Profile
• Others: Calibration, Operation and Maintenance as per In-house standard operating procedures of Analytical Instruments like Micro Balance, Karl fischer Auto titrator, Osmometer, TOC analyzer, pH and conductivity meter, Analytical Balance, Centrifuge, Rota evaporator, Turbo evaporator, Micro pipettes

• Good Knowledge and exposure in Analytical Method Development and Validation as per regulatory requirement.
• Exposure of working in a GMP lab with good documentation procedures.
• Exposure of working experience in a green field project which helped to set up a complete laboratory. Like qualifications (IQ, OQ and PQ) of instruments like HPLC, TOC, Karl fischer and auto titrator osmometer etc.
• Good exposure in Proficiency Testing Programs (PT).
• Good exposure in Instruments calibration and troubleshooting of various analytical instruments like HPLC, TOC, Karl Fischer, pH and conductivity meter, Analytical balances, Osmometer and UV spectrophotometer etc
• Can Handle stability Instruments like BOD incubators, Humidity chambers and cold chambers.
• Wide exposure with the documentational works regarding the coordination of quality control with Quality assurance.
• Can handle QMS tools like change controls, Incidents etc
• Wide exposure to Quality control, Method Validations, Compliance and regulatory areas.
• Analysis of molecular size distribution of plasma related proteins like Human albumin and Human normal immunoglobulin proteins by HPLC - SEC method.
• Analysis of Toxins like Ochratoxin A and Aflatoxins-G1G2B1B2 by HPLC FLD.
• Analysis of Fat soluble Vitamins like Vitamin A, D, E etc.
• Method development for extraction, clean up and analysis of Toxins, Vitamins, Antioxidants Preservatives etc.
• Good knowledge and practical experience on sample preparation techniques by using SPE (Solid phase extraction).
• Analysis of Amino acids By HPLC DAD.
• Analysis of Alkaloids such as Caffeine, Pipperine, N-Vanillylnonanamide.
• Preparation of Standard Operating Procedures (SOP), Method Validation Protocols, Method Validation Reports (MVR), and other lab documents.
• Conducting periodical trainings to junior level scientists.

• NABL (National Accreditation Board for Testing and Calibration Laboratory)
• BIS (Bureau of Indian Standards)
• CDSCO audits
• Customer Audits

• Lab Solution Software for SHIMADZU VWD
• Empower Software By Waters
• Open Lab software with Control Panel For Agilent 1260 infinity
• Open Lab software with CDS for Agilent 1290 infinity 2

• Father's Name: Narayanaswamy PM
• Date of Birth: 10/07/95
• Gender: Male
• Nationality: Indian
• Marital Status: Single