Provides project leadership and guidance on validation/qualification initiatives to internal project teams and ensure project schedules are met. Ensures that West-Ward Pharmaceuticals systems, both computer and equipment, are in compliance with regulatory requirements through maintaining change control process and conducting periodic reviews.
Bachelors degree in engineering or related scientific discipline required with a minimum of four (4) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting.
Require 1-3 years specific software or equipment validation experience in a pharmaceutical environment. Experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience preferred.
Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols and/or technical reports preferred.