22404-QA Specialist Validation & NPI-Carlow Contractor

Purpose:

In this role, you will play a vital role in supporting the introduction of new products and Quality oversite of executed validation completed at our Carlow facility. As the QA Specialist for Validation and New Product Introduction (NPI), you will be an essential member of our esteemed Technical Transfer/Validation Team. This team holds responsibility for managing the development and manufacture of vaccines and biological products. Alongside your day-to-day QA activities, your main focuses will be reviewing and approving all Validation documents relating to a sterile facility including cleaning validation ensuring to support corporate compliance and regulatory expectations for manufacturing. You will report to the Associate Director of Quality and collaborate closely with cross-functional teams on-site, particularly Technical Engineering. Your key objective will be to ensure that manufacturing, technical, and regulatory requirements are met.

Responsibilities:

• Provide quality oversight and direction for the introduction of new products.
• Serve as the point of contact for quality at both the site level and with external inputs coordinating and attending Quality working group meetings.
• Participate as a functional expert in the cross-functional team responsible for introducing products at Carlow.
• Conduct quality reviews& approval 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. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency.
• Actively participate in Plant/Quality committees and collaborate with other site functional groups.

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.
• Strong report, standards, and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired.
• Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
• Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
• Proven ability to drive the completion of tasks.
• Strong decision-making capability with a sense of accountability and responsibility.