IT Compliance

Tasks

- Ensure IT complies with applicable policies and procedures, training requirements, and applicable regulatory requirements; 
- Interpret and communicate systems compliance regulations within the IT function, leveraging Industry learnings, guidance (GAMP), and peer benchmarks; 
- Plan, facilitate the preparation/ coordination, and follow-up on audit/inspection findings and lessons learned; 
- Facilitation of GMP policies, narratives, and control self-assessment documentation; 
- Create and maintain IT compliance documentation and knowledge repository; 
- Develop recommendations to improve the IT internal control environment; 
- Responsible for ensuring that Information Technology’s systems are developed and maintained in compliance with GxP regulations, and according - Provide senior-level consultation and direction to functional areas on IT Compliance for policy, process, and procedure; 
- Identify, propose, initiate, and lead significant improvement initiatives related to Compliance policy, process, and procedure. 

Skills

  • Knowledge of Software Testing
  • ISTQB or equivalent
  • Technical Documentation
  • SW testing automation tools
  • Quality Assurance Driven
  • Previous experience in Pharma is a plus
Details
Activated at 02/22/2019
Locations Lisbon | Portugal
Category Consultants
Contact Nathalie MADEIRA
Reference AD002131