M Sc.(Chemistry)From Department of Chemistry, University of Pune in 1992
B Sc. (Chemistry) From S.S.G.M. College, Kopargaon (MH) in 1990
Experience in the Pharmaceutical and Chemical industries. Dependable and committed to quality with exposure to implementing and monitoring ISO, GMP & cGLP norms and process improvement measures. Interested in managing QC or Analytical Development operations in a well equipped laboratory of an organization of repute.
Quality Control
Analytical Development & Validation / cGMP & cGLP
Calibration & Standardization of HPLC,GC. UV Spectrophotometer, FTIR , AAS, Flame photometer, Polari meter, Conducto meter, RI, pH meter.
RM/In process/FP Analysis
Wet Lab Analysis, Working Standard Preparation & Standardization
Stability tests as per ICH Guidelines,
Vendor Development
Administration & Trainings
Microbiological testing
Preparation and Review of SOP, STP, Specifications, Protocols, COAs, MSDS.
Customer Complaints, OOS, CAPA, Document Change Records
Documents & Records
Vendor Audits & Quality Audits
Troubleshooting
Deputy Manager, QA
Since Jul 2015
Company Profile:Manufacturer of chemical intermediates, specialty resins and solutions
QC/QA Manager
April 2014 to July 2015
Company Profile : Manufacturer of agro-chemical inputs. products are Alachlor, Herbicided Weedicides & Herbicided Weedicides.
Head QC
Jan 2010 to April 2013
Company Name : Ind Frag Ltd
Research Scientist
May 2007 to Dec 2009
Company Name : Ranbaxy Research Laboratories Ltd.
Senior- QC Officer
Jan 1996 to Apr 2007
Company Name : Gharda Chemicals Ltd.
Senior Chemist
Nov 1993 to Jan 1996
Company Name : Sudarshan Chemicals Industries Ltd.
Chemist
Aug 1992 to Nov 1993
Company Name : Shree Products
Career Profile
QC & Analytical Development:
Proficient in calibration, standardization, and qualification of instruments as also their maintenance and troubleshooting when required.
Hands-on experience in Pharma,chemical, wet-lab analysis as well as instrumental analysis using HPLC, GC, IR, UV-Spectrophotometers, KF-Titrator, Polarimeter, Particle Size Analyzer, AAS, Turbidimeter, Dissolution Apparatus, Flame photometer.
Independently managing QC operations including allocation of work; ensuring compliance of cGLP and SOPs; inventories of Lab chemicals & glassware etc., vendor sourcing/development; Monitoring of preparation & standardization of solutions, reagents and their storage & retention of samples.
Highly experienced in analysis of a wide range of both pharmaceuticals
(API & their formulations)and chemical- finished products, raw materials, in process samples, abnormal materials, stability studies of API and their formulation as per ICH guidelines.
Taking corrective action for customer complaints, OOS, Preparation & standardization of working standard and maintain the reports.
Adapt and monitoring quality aspects at every step, conducting quality audits and facing ISO Audits, ETP, Process water, Drinking water & boiler water analysis, stack gas & ambient air analysis, Analysis of Exhibit Batch Samples with Innovator samples for submitting data to Regulatory-Bodies, monitoring Microbiological analysis, Food analysis, Cosmetic analysis, Medicinal herbal & Nutritional products analysis.
Analytical Development
Developing analytical methods for samples and new
raw materials; standardizing the reaction schemes; working on reducing
cost of analysis, multimedia dissolution study for pharmaceutical
formulation for innovator matching.
Documentation:
Experienced in preparing certificates & reports of analysis for RMs &
In-process, FPs, maintaining documents and records. Preparing specification of RM & FP, Investigation of OOS. Calibration & preventive maintenance of Instruments.
Preparing SOPs, formats and protocols for finished product, intermediate and raw materials and verifying quality activities comply with respect to GMP standards.
Administration:
Training & development of Lab staff by identifying training needs and planning the required programs.
Handling inter-departmental and cross-functional coordination for day-to-day operations and successfully discharging duties as Head QC.
Trainings attended: ISO-9000/ISO-14000, Industrial Safety.
Dependable and committed to quality with exposure to implementing and monitoring ISO, GMP & cGLP norms and process improvement measures. Interested in managing QC or Analytical Development operations in a well equipped laboratory of an organization of repute.
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