Ankur Bishnoi
C/O, Mr.Madan Singh Chauhan,
Kavi Nagar Gajraula (U.P), India
Mobile : +91-8057879008
Email : - akmicrobiology AT Yahoo.com
Middle Management Professional
Quality Control
Professional Profile :
** MSc In Microbiologyy with 10.0 years of rich experience in quality control, laboratory Management, stability studies, Microbiology & working standard management.
** BSc in Chemistryfrom M.J.P.ROHILKHAND Bareilly (UP) in 2004.
** Presently working with Teva API India Ltd. as Quality Control GCA 10, Senior Quality Executive, Gajroula (U.P) Since Dec-2014 to till Date.
** Designated at Windlas Biotech Limited as Quality Control Exexcutive, Deharadun (U.K) From Aprail-2012 to Nov-2014.
** Designated at Cipla Ltd, as a Management Quality Control Staff, Indore (M.P) From Jan-2011 To Feb-2012.
** Designated at Sun Pharma Ltd. Jammu and Sikkim, As Quality control cum Microbiologist from October. 2008 To Dec.2010
** An Out-of-the Box thinker with sound quality control knowledge and through knowledge of laboratory operations.
** The wealth of expertise covers all quality control affairs which include trouble shooting in day to day work, work planning ,data reviewing , and OOS and OOT reviewing.
** Possess analytical skills in Chromatography.
** Proven ability to ensure lab compliance ,21CFR Part 11
** Proficient in imparting training to new entrants and supervise a 15 members team in Q.C.
** A multi tasked professional with strong analytical, problem solving and interpersonal skills.
** Quick learner and ability to learn new things wherever necessary
Core Competencies :
** Quality control Experience
** Stability study Management
** Operational Excellence in Q.C
** Change Control management
** Laboratory standards Management
** Training on monograph and SOP’s
** Deviation management
** Data reviewing for FDA TGA etc.
** Lab Management
** 21-CFR-PART-11
** DQ, IQ, OQ & PQ
** Customer support expert.
** Routine FG, RM, Raw material & stability study analysis.
** Preparation of SOP’s
Career Highlights :
** A member of the team to achieve 2008 WHO approval of facility for Sun Pharma Ltd.
Sikkim.
** Approved In Microbiology Section from SIKKIM FDA in 2009.
** Members of team achieve 2011 MHRA and TGA for various product in Cipla Limited Indore.
** Members of team achieve PMDA-2014, FDA-2015-, & TGA 2015, FDA 2018 Audit on Various products in TEVA API INDIA Pvt. Ltd. (Gajroula).
** Many customers’ audits face for different API Products.
Technical Skill Set Hands on experience :
** High performance liquid chromatography.
** HPLC & UPLC(Make : Shimadzu, Waters, Agilent with UV, Dionex, Acquity H Class, Nexera FLC)
** Alliance (waters) 2695 separation modulewith Empower 2 software on CDS System.
** Agilent 1100 separation modulewith Empower 2 software
** IQ, OQ, PQof newly introduced equipments.
** Calibration of High performance Liquid chromatograph after PM.
** Calibration of pH Meter and Balance.
** Review Calibration data of stability chambers & Hygrometers by third party.
** Calibration of Analytical Balances after PM.
** UV spectrophotometer & IR.
** Handling deviations(LIR, OOS & OOT) in Track wise software.
** Working standard management expert& prepared COA’s for internal & external use.
** Handling of instruments : DT apparatus, Friability apparatus, Disso & Hardness Tester.
** To review of calibration reports of Q.C Instruments/master instruments (Calibrated from outside agency).
** Monitoring of Instrumental analysis of finished products, Intermediate and Raw materials.
** Working experience on software used in Laboratory LIMS, Trak wise,QCMS & LAB-X
Personal Vitae :
Correspondence Address : C/o Mr. Madan Singh Chauhan, Kavi Nagar, Gajroula, Dist.-Amroha (U.P) India.
Permanent Address : Village+Post-Hafizabad, Dist-Bijnor (U.P)INDIA.P.N.-246747
Date of Birth : 15.12.1984
Languages Known : English, and Hindi
Declaration :
The information given above is true & best of my knowledge
Date :
Place :