Provides project leadership and guidance on large/complex 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. Assumes major role during agency inspections. Investigates and makes sound recommendations for validation compliance concerns or new regulations.
Bachelors degree in engineering or related scientific discipline required with a minimum of eight (8) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting. Require minimum 5 years specific software or equipment validation experience in a pharmaceutical environment. Three years experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience preferred.
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.