Niraj Muley
A Post Graduate in Chemistry with 21 + years of experience and Proven track record of performing advanced duties in Formulation Analytical Research (ADL),DQA,QC & Analytical QA (Analytical Compliance)
- Role
- Deputy Manager in Analytical Qa or Analytical Complience or Quality Group at Fdc Limited
- Location
- Aurangabad, MH, IN
- LinkedIn followers
- 500 followers
About Niraj Muley
A Post Graduate in Chemistry with 22 + years of experience and Proven track record of…
Experience
Deputy Manager in Analytical Qa or Analytical Complience or Quality Group
Oct 2017 — Present
Analytical Raw Data Review of Finished product batches of US & UK before batch Release for Adequacy & Accuracy.Electronic Raw data review and Audi trials review of HPLC, GC, UV, IR, Auto titration, and Dissolution for Compliance purpose and well versed with the requirement of 21 CFR Requirements.Responsible for Investigation, Review & approval of OOS,OOT Results, Analytical Incidences, Analytical Deviations, Involved in Investigational analysis.Drafting the OOS, OOT, Analytical Incidences, Deviation in scientific way by taking in to consideration of ICH Guidelines & USP General Chapters for scientific rationalesResponsible for Review & approval of Instrument Qualification protocols & reports of QC Instruments (URS,DQ,IQ,OQ & PQ,UMCS and Traceability Matrix ) Responsible for Appropriate CAPA taken & its effective implementation in QC Lab.Actively participated in the audits as a team member for regulatory agencies like USFDA, MHRA, PICS and TGA etc.Responsible for Internal Audits (self–inspection) of QC Department and keeping track on Compliance & CAPA taken against the observations of self Inspection.Review and approval of QMS documents i.e. change control / deviations / LIR / Chromatographic errors, trends for non-conformance.Review of Risk assessment, Quality technical agreements with contract laboratories Training to Team Members on GLP, GDP & Good Chromatographic practices.Preparation, Review & approval of Different QC Related & ADL Related SOP’s.Responsible for the preparation, review & approval of Nitrosamine Impurities Evaluation & Control strategies Report of finished Products of FDC’s LTD
Education
DSM College Parbhani ( Swami Ramanand Teerth Marathwada University Nanded Maharashtra)
M. SC, Organic Chemistry
2000 — 2003
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