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QA Auditor and Chemist

Location:
Trenton, New Jersey, United States
Posted:
September 26, 2018

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Resume:

ARJUN SHETH

*** ****** ***

Hamilton, NJ *****

609-***-****

Email: ac66or@r.postjobfree.com

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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