Provide project leadership and guidance on validation/qualification initiatives to internal project teams and external validation firms and ensure project schedules are met. Ensures that West-Ward Pharmaceuticals systems, both computer and equipment, are in compliance with regulatory requirements. Investigates and makes sound recommendations for validation compliance concerns or new regulations.
Demonstrated experience in equipment qualification and software validation across multiple applications, systems and equipment types required. Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols and/or technical reports.
Minimum 5 years experience in project management required with demonstrated ability to manage multiple simultaneous projects.
Knowledge of FDA Current Good Manufacturing Practices (cGMP), GAMP 5 requirements and 21 Code of Federal Regulations (CFR) Part 11 requirements.
Experience and Inspection interaction with FDA, EMA or other regulatory agencies preferred.