Sr Quality Assurance (Validation) Engineer - FL, USA

The Sr Quality Assurance (Validation) Engineer is responsible for Quality oversight of the local validation program, improving systems/applications quality, and providing recommendations for improvement opportunities. The engineer will approve validation, change control, and investigation of events, as well as provide Quality oversight and/or Quality approvals for GxP systems.

Requirements

• Bachelor's degree in Computer Science / Computer or Biomedical Engineering
• Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance
• Demonstrated knowledge of predicate rules such as GLP, GMP, GCP, GAMP 5 as they relate to computerized systems
• Comprehensive knowledge of FDA, EMA, JP, ISO and other regulations and experience in US and international regulatory agency inspections
• Knowledge of regulations and practices pertaining to pharmaceutical/medical devices products in your area of responsibility
• Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations
• Excellent oral and written communication skills with strong technical writing experience required
• Experience in internal / external audits, identify findings, drive resolution and provide closure report
• Proficient skills in solving complex problems and ability to bring issues to resolution
• Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities