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.
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