Chemist Quality Control - Pharma
Handymen - Working specialties
Experience:
Quality control professional with more than 15 years of experience in the Pharmaceutical Industry. Knowledgeable and experienced as an Analytical Chemist. Proficient in quality management systems, GxP practices, and industry-standard regulations. Proven skills in pharmaceutical analytical techniques (wet analysis and instrumentation techniques). Adept at handling different segments germane to electronic data review & compliance, Laboratory investigations.
Education:
MASTERS IN SCIENCE (M.Sc) Apr 2009 - Mar 2011
SRI VENKATESHWARA UNIVERSITY | TIRUPATHI, INDIA
M.Sc Analytical Chemistry: Specialized in pharmaceutical Instrumentation techniques and complete wet chemistry Pharmaceutical analysis.
Skills:
Quality control professional with more than 15 years of experience in the Pharmaceutical Industry. Knowledgeable and experienced as an Analytical Chemist. Proficient in quality management systems, GxP practices, and industry-standard regulations. Proven skills in pharmaceutical analytical techniques (wet analysis and instrumentation techniques). Adept at handling different segments germane to electronic data review & compliance, Laboratory investigations.
Proficient knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
Responsible for documentation compliance and report deviations from specifications and tolerances
Receive and register documents for data entry in Laboratory Information Management System (LIMS)
Knowledgeable in computer software and MS Office.
Team management and Responsible for routine activities in the laboratory.
Performed analytical instrumental and wet chemical analysis for Pharmaceutical Products.
Performed calibration for analytical instruments- HPLC, GC, UV, IR, SOR, and MR.
Technical writing of protocols and reports.Empower3 software audit trail verification and Document Review.
Developed analytical instrument qualifications germane to URS, validation plan, DQ, IQ, OQ, PQ, and CSV.
Responsible for Reference Standards management.
Responsible for compendia changes evaluation with current standard testing procedures,
Preparation of SOPs and periodic revisions. Laboratory incident investigations in the track-wise application.
Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise.
Significant knowledge and experience with compliance requirements.
Additionally:
HANDS-ON EXPERIENCE IN ANALYTICAL INSTRUMENTS
HPLC and GC (Agilent and Shimadzu HPLC-2010 CHT models and UPLC with Empower-3),Wet Chemistry - UV-Vis, FT-IR, KF -Potentiometer, SOR, NMR, XRD and MALVERN particle size.etc).
