Quality Assurance Specialist for Validation and New Product Introduction
We are seeking a highly skilled Quality Assurance Specialist to join our quality team at our Carlow facility. As the QA Specialist for Validation and New Product Introduction (NPI), you will play a vital role in supporting the introduction of new products and ensuring the quality oversight of executed validation.
About the Role:
* Review and approve all Validation documents relating to a sterile facility, including cleaning validation.
* Support corporate compliance and regulatory expectations for manufacturing.
* Collaborate closely with cross-functional teams on-site, particularly Technical Engineering.
Responsibilities:
1. Provide quality oversight and direction for the introduction of new products.
2. Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
3. Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
4. Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
5. Review documentation associated with new product, such as, QC Test Specifications, BOMs, and MES documentation.
6. Support deviation close out in a timely manner.
7. Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
8. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency.
Requirements:
* A Bachelor's degree or higher in a related Science discipline is preferred.
* A minimum of 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 (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.