A Quality Assurance Specialist plays a vital role in supporting the introduction of new products and ensuring quality oversight within a leading Biopharmaceutical Multinational. As a member of the Tech Transfer/Validation Team, you will provide quality direction for new product introductions, serve as a point of contact for quality at both site and external levels, and participate in cross-functional teams responsible for introducing products.
Key Responsibilities:
* Provide quality oversight and direction for new product introductions
* Serve as point of contact for quality at site and external levels
* Participate in cross-functional teams for new product introductions
* 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 products, including 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
Qualifications and Experience:
* Bachelor's degree or higher in a related Science discipline preferred
* Minimum 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment
* Experience in reviewing and approving documents associated with equipment validation, cleaning validation, sterilization, and quality oversite of equipment qualification
* 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) preferred
* Strong report, standards, and policy writing skills
* Proficiency in Microsoft Office and job-related computer applications