Regulated Applications Consultant

Title: Lead Regulated Applications Consultant (CSV/PART 11)

Type:    Contract Relationship

Assignment Information:                  

Senior regulated industry applications IT professional with 20+ years of quality and compliance experience including principles of software quality assurance, software validation, information security and 21 CFR Part 11. Familiar with all aspects of quality system business processes and FDA-regulated manufacturing and laboratory operations.   Demonstrated accomplishments in:

  • SAP configuration and software validation principles including, but not limited to, master data management, queries, and security profiles
  • Operational software quality – quality and validation programs for software products marketed to regulated industries
  • User Requirements Specifications
  • Software Requirements Specifications
  • Preparation of company SOPs for document control, change control, training, and manufacturing
  • GxP training, authoring GxP procedures
  • Document and record controls
  • Adverse event reporting, CAPA, and compliance auditing and associated software applications

Preferred Education:                  

Degree in engineering, information systems, information management or related discipline, or other scientific / technical degree in necessary combination with relevant industry experience.

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