IT System Validation Specialist
About the Job
Medical Device Manufacturing!
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 oversighton 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.
Qualified candidates will have:
Bachelors degree in IT or Engineering
Professional certification orexperience in Information Systems / Technology related compliance within an FDA, EMEA, GMED or TGA regulated industry
Five (5) years experience performing/ supporting Computer System Validations (CSV).
Experience in SDLC management.
Experience with SOX and GAMP 5 preferred
To apply, please send resume todayto [click on "Apply Online" button]