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Compliance Specialist

Job Post Index 209E6E-Sy##
Location New Brunswick, NJ
Description: Description
  • Provide quality assurance and regulatory compliance oversight across the end-to-end product lifecycle for software development and validation lifecycle activities
  • Associate with regulated computerized systems to ensure conformance to cGxPs,
  • Provide QA oversight for the management of electronic records or electronic signatures in compliance with world-wide health authority regulations, guidance documents, applicable industry standards and company requirements.
  • Review computerized systems validation.
Skills: Qualifications
  • Experience and training in FDA GMP, GLP and GXP regulations including equipment, process cleaning and CSV.
  • Experience in CQA/CQE preferred
  • Excellent technical writing skills and knowledge of MS Word, Excel and Project
  • Strong validation experience needed.

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