+1 908 704 8843      270 Davidson Avenue, Suite 103, Somerset, NJ 08873
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Represent the site quality organization with expertise in Data Integrity. Maintain currency with U.S. and European regulations related to Data Integrity. Perform Data Integrity risk assessment of manufacturing and laboratory systems. Evaluate proposed and existing manufacturing equipment, ...

Job Description

  • Represent the site quality organization with expertise in Data Integrity.
  • Maintain currency with U.S. and European regulations related to Data Integrity.
  • Perform Data Integrity risk assessment of manufacturing and laboratory systems.
  • Evaluate proposed and existing manufacturing equipment, instrument systems and laboratory applications for Data Integrity gaps.
Required:
  • Relevant quality assurance experience including expertise in GMP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry
  • years working in a GMP regulated environment
  • years of experience quality role
  • years of experience in a computer systems validation
  • Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity
  • Expertise in all aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint )