Experienced IT Computer System Validation Specialist needed to focus on SDLC processes and document development as well as infrastructure/hardware qualifications.
This position is responsible for ensuring that GxP regulated computer systems are in compliance with regulatory requirements, company policies and procedures.
- Provide compliance leadership, direction and oversight to project teams in SDLC document development and maintenance.
- Lead the development and execution of SDLC documentation including Risk Assessments, User Requirements and Configuration Specifications.
- Participate in developing and approving documentation for: Gap Assessments, System Validation Master Plans, IQ/OQ/PQ, System Validation Final Reports, Trace Matrices.
- Lead the development and execution of IT Infrastructure Qualifications
- Bachelor’s degree in IT or Engineering
- Professional certification or training/ experience in Information Systems (IS)/Technology related compliance within an FDA, EMEA, GMED or TGA regulated industry
- A minimum of five (5) years experience performing/ supporting Computer System Validations (CSV).
- Experience in SDLC management.