Massachusetts

(413) 535-9847

Guiding life science companies to regulatory compliance

Guiding life science companies to regulatory compliance

Guiding life science companies to regulatory complianceGuiding life science companies to regulatory compliance

Job Openings

JOB TITLE: GXP Data Integrity Auditor

POSITION OVERVIEW:

The GXP Data Integrity Auditor requires comprehensive knowledge in Software Validation, FDA and EU Data Integrity Regulations, and Data Integrity.  This person will participate in the audit of highly complex and specialized vendors and systems.


WORKING KNOWLEDGE OR EXPERTISE IN:

  • Annex 11
  • 21 CFR Part 11
  • GAMP 5
  • Software validation practices and Software Development Life Cycle (SDLC) models
  • Agile and Waterfall SDLC methodologies
  • Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems
  • Cloud Based Systems
  • Requirements analysis, Design analysis, Validation Plans, Configuration controls, and Source Code Repository controls
  • Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)
  • Software Risk Management Principles
  • Data Integrity Principles


CORE JOB RESPONSIBILITIES:

Main responsibilities include:

  • Evaluates vendor quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements
  • Authors audit agenda and audit reports
  • Executes computerized system audits
  • Assesses vendor responses to audit findings
  • Facilitates pre and post audit communications with the vendor
  • Facilitates the client related audit pre-scope and debrief activities
  • Responsible for providing guidance and support to Compass Life Science Solutions’ clients regarding audit results
  • May assist with helping a client validate a computerized system and may establish client specific non-product computerized software validation (CSV) validation processes
  • Travel: up to 75%


MINIMUM QUALIFICATIIONS:

  • Bachelors degree
  • Minimum 5 years of executing vendor audits
  • Extensive FDA and EU regulatory experience related to computerized systems, electronic signatures and records, audit trails, and data integrity
  • Risk Management/Assessment experience
  • Minimum 5 years Software and Computer Systems Validation experience, along with cyber security and data integrity experience
  • Extensive Software Development Life Cycle (SDLC) experience and analysis
  • Strong technical skills, e.g. technical writing 

PLEASE FILL OUT FORM BELOW TO APPLY