QA Auditor and Chemist
Resume:
ARJUN SHETH
Hamilton, NJ *****
Email: *.*****@***.***
PROFESSIONAL EXPERIENCE
CATALENT Pharma Solutions, Somerset, NJ June 2012-September 2018 QA Auditor
• Reviewed and approved stability documents, method validation, and method transfer to ensure that all direct reports adhered to the cGLP/cGMP and prescribed specifications.
• Audited analytical data and laboratory reports.
• Audited laboratory notebooks, analytical test methods and protocols for compliance to SOPs and QA agreements.
• Reviewed and approved deviations, investigations, CAPAs, and other track wise reports.
• Reviewed and audited microbiological tests, environmental and safety responsibilities.
• Participated in laboratory investigations; reviewed the OOS/OOT and lab events.
• Performed metrics for lab analysts and submitted to MQR slides.
• Conducted and documented the GMP and SOP training. APRECIA Pharmaceutical Company, East Windsor, NJ December 2011-June 2012 QA Specialist (Temporary Position)
• Performed 100% audit of process documents/log books to ensure completeness and accuracy for assigned focus factory.
• Performed GMP walk through inspections of assigned departments within the factory.
• Performed auditing laboratory notebooks, test methods and protocols. Wrote and modified SOPs.
• Reviewed and approved deviations, investigations and CAPA. Audited instrument calibration.
• Released raw material and finished products after auditing the records.
• Conducted internal audit and training program for the new employees. JANSSEN Pharmaceutical, J&J division, Titusville, NJ June 1998-October 2011 Senior Scientist, QA/QC Department
• Performed and analyzed stability samples by using various analytical instruments such as HPLC, Dissolution, Uv-vis, KF, GC, etc.
• Analyzed process validation and marketed samples.
• Wrote and performed SOP’s.
• Validated analytical methods.
• Engaged in Method Transfer.
• Ensured that all laboratory notebook and documents are complete and in compliance with cGMP/GLP.
• Analyzed an analytical data and identified trends.
• Maintained up-to-date records for all worked performed.
• Performed laboratory deviation investigation, OOT, OOS investigation.
• Familiar with LIMS and Empower software.
• Trained other chemists in proper laboratory techniques. PARKE-DAVIS, Division of WARNER-LAMBERT, Morristown, NJ March 1996-May 1998 Assistant Sr. Scientist, Analytical R&D
• Developed and validated analytical methods and reported results according to the GMP/GLP.
• Analyzed stability samples of various dosage forms and reported data according to GMP/GLP.
• Quantitative and instrumental analysis including operation and trouble-shooting of HPLC and Dissolution.
• Trained new analysts.
• Assisted in the transfer of analytical methods to QC lab and in development of HPLC method.
• Performed Preparative HPLC analysis.
CARTER-WALLACE INC., Cranbury, NJ October 1985-February 1996 Chemist, Analytical R&D
• Performed routine and non-routine analyses in support of analytical research, both independently and as part of a team. Assisted in training other technical staff in the operation of laboratory equipment.
• Performed analysis of investigation dosage forms and drug substance for clinical.
• Assisted in the development and validation of analytical method for filing IND and NDA submission.
• Improved instrumentation status by trouble-shooting mechanical problems.
• Adapted HPLC procedure for Zymark robot to ensure content uniformity of tablets. Results were accurate, faster and reproducible.
• Analyzed stability samples submitted by formulation group, using HPLC, UV, TLC, Dissolution, KF etc.
• Worked on special projects to answer NDA questions.
• Maintained laboratory instruments and documentations to comply with GMP/GLP requirements.
EDUCATION
South Gujarat, Surat, India
Bachelor of Science in Chemistry
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