The QA Validation Specialist will play a vital role in supporting the introduction of new products and quality oversight of executed validation completed at our facility. This is an 11-month contract role.
Responsibilities:
* Provide quality oversight and direction for the introduction of new products.
* Serve as the point of contact for quality, coordinating and attending quality working group meetings.
* Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
* Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
* Review documentation associated with new product, such as QC Test Specifications, BOMs, and MES documentation.
* Support deviation close out in a timely manner.
* Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
Requirements:
* Bachelor's degree or higher in a related science discipline.
* Minimum 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
* Familiarity with cGMP and GDP preferred.